Firelands Scientific Jobs in Usa

About the Role

The Chief Scientific Officer - Early Drug Development will formulate and lead the company's global early-stage R&D strategy, establishing the R&D roadmap from target validation to proof-of-concept (POC).

Responsibilities

• Lead the drug chemistry team and the biology team.
• Establish a global R&D layout and talent echelon for innovative drugs of Qilu.
• Plan and make decisions regarding the innovative drug pipeline, including cutting-edge technology fields such as small molecules, large molecules, ADCs, and small nucleic acids.
• Establish strategic partnerships with the global academic community, research institutions, and biotechnology companies to introduce cutting-edge technologies.
• Research on leadership mechanisms and formulate biomarker strategies to provide a solid scientific basis for R&D decisions.

Qualifications

• Possess a doctoral degree in life sciences or a related medical field.
• Over 20 years of research and development experience in multinational pharmaceutical companies or top biotech firms.

Required Skills

• Profound biological knowledge in core disease areas such as oncology, metabolism, autoimmunity, or the central nervous system.
• Deep understanding of emerging therapeutic modalities.
• Complete R&D success experience from the laboratory to the clinic.
• Led and advanced at least five innovative drug projects into the clinical stage and successfully completed POC.
• Outstanding scientific insight and strategic decision-making ability to predict industry trends and transform them into the company's R&D advantages.
• Outstanding leadership with the charisma and influence to inspire, attract, and retain top scientific talents.

Preferred Skills

• Experience in establishing and managing global R&D teams.
• Strong network within the academic and biotechnology communities.

Pay range and compensation package

Competitive salary and comprehensive benefits package commensurate with experience.

首席科学官 - 早期药物研发

工作职责：

• 制定并领导公司全球早期研发战略，确立从靶点验证到POC的概念验证的研发路线图。
• 统领药物化学团队、生物学团队，构建齐鲁创新药物全球研发布局与人才梯队。
• 主导创新药物管线的规划与决策，包括小分子、大分子、ADC、小核酸等前沿技术领域。
• 作为公司科学领域的最高代表，与全球学术界、研究机构及生物技术公司建立战略合作，引进前沿技术。
• 领导机制研究与生物标志物策略的制定，为研发决策提供坚实的科学依据。

任职要求：

• 拥有生命科学或医学相关领域的博士学位，20年以上在跨国药企或顶尖生物技术公司的研发经验。
• 具备深厚的肿瘤、代谢、自身免疫或中枢神经系统等核心疾病领域的生物学知识，并对新兴治疗模式有深刻理解。
• 拥有从实验室到临床的完整研发成功经验，曾主导推进至少5个创新药物项目进入临床阶段并成功完成POC。
• 卓越的科学洞察力与战略决策能力，能够预见行业趋势并转化为公司的研发优势。
• 出色的领导力，具备激发、吸引和保留顶尖科学人才的人格魅力与影响力。
• 具体岗位职级将根据候选人综合资质确定。

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.

The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.

Key Responsibilities

• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.

• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.

• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.

• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.

• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.

• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.

• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.

• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.

• Minimum 1 year of leadership, supervisory, or management experience (preferred).

• Prior experience in manufacturing, quality, or engineering is required.

• Excellent communication, leadership, and organizational skills.

• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.

Preferred Qualifications

• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.

• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

Physical Requirements

• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Regular, punctual attendance is required.

• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.

• Must be able to lift up to 25 lbs.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be able to sit or stand for extended periods.

• Must be willing to work with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.

Sr. Quality Control & Sample Management Specialist

Our client is looking for an experienced QC and sample management professional to support high‑quality data generation within our Translational DMPK and Clinical Pharmacology team. This role ensures accuracy, compliance, and smooth sample lifecycle management across internal and external studies.

Responsibilities

• QC review of bioanalytical data (LC‑MS/MS, ELISA, qPCR) and study documentation from internal teams and CROs
• Manage and review scientific documents in SharePoint
• Format internal reports and provide templates to CROs
• QC review of packing slips, manifests, and critical reagent documentation
• Contribute to drafting and editing bioanalytical lab guidelines
• Routine QC of Electronic Lab Notebooks
• Audit finalized reports and maintain errata
• Use LIMS (LabVantage) for sample receipt, tracking, aliquoting, storage, shipping, and disposal

Requirements

• Bachelor’s degree in a scientific or healthcare field
• 5+ years QC experience in pharma, biotech, or CRO environments
• Proficiency with LIMS (LabVantage preferred) and electronic notebooks
• Strong understanding of GxP regulations
• Excellent attention to detail, communication, and organizational skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with bioanalytical assays is a plus

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.

Position Overview

We are seeking Senior Scientists to develop agentic AI systems that transform how drug discovery research is conducted. As part of the AI/ML Foundation team, you will build autonomous AI agents capable of reasoning, planning, and executing complex scientific workflows—from literature synthesis and target identification to experimental design and data analysis. This role requires a unique combination of expertise in large language models, agentic frameworks, and understanding of drug discovery processes. You will translate standard research workflows into agentic frameworks, develop new agent skills, and deploy systems that augment scientist productivity across Computational Sciences and Global Research.

Accountabilities:

• Develop agentic AI systems for drug discovery applications including target-disease association, automated literature search and synthesis, hypothesis generation, and intelligent design of experiments.
• Translate standard research workflows into agentic frameworks—decomposing complex scientific processes into autonomous agent tasks that can reason, plan, execute tools, and iterate based on results.
• Design and implement new agent skills (tools, functions, APIs) that extend agentic capabilities to specialized scientific domains including molecular design, property prediction, assay planning, and data analysis.
• Build agentic systems that integrate with foundation models and external knowledge sources for autonomous hypothesis generation, evidence retrieval, and scientific reasoning.
• Develop retrieval-augmented generation (RAG) pipelines connecting agents to internal and external scientific literature, databases, and experimental results.
• Partner with research scientists to understand workflow needs, validate agent outputs, and iterate on system design to ensure scientific rigor and utility.
• Stay current with advances in agentic AI, LLM applications, and scientific automation; contribute to internal knowledge sharing and external publications.

Educational & Requirements:

• PhD in Computer Science, Computational Biology, Bioinformatics, or related field with 2+ years relevant experience, OR MS with 6+ years relevant experience.
• Strong experience with large language models (GPT, Claude, Llama) and their application to complex reasoning tasks.
• Proficiency in Python and experience with agentic AI frameworks (LangChain, AutoGen, CrewAI, or similar).
• Experience building RAG systems including vector databases, embedding models, and retrieval pipelines.
• Understanding of drug discovery processes and scientific research workflows.
• Strong problem-solving skills and ability to translate complex scientific processes into computational workflows.

Preferred:

• Experience in pharmaceutical or biotech R&D environments.
• Background in biology, chemistry, or disease biology.
• Experience with reinforcement learning or planning algorithms for agent decision-making.
• Familiarity with scientific databases (PubMed, UniProt, ChEMBL) and APIs.
• Experience deploying AI systems in production environments.
• Track record of publications or presentations on LLM ap

Additional Competencies Common in Strong Candidates

• Ability to lead cross-functional initiatives and mentor junior scientists.
• Experience in translating computational insights into experimental strategies.
• Strong publication record or demonstrated thought leadership in AI for biology and molecular design.
• Comfort working in fast-paced, innovation-driven environments with evolving priorities.

ADDITIONAL INFORMATION

• The position will be based in Cambridge, MA

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Worker Type

Worker Sub-Type

Time Type

Job Exempt

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• Support the setup and launch of the new Process Technologies & Development lab, including workspace organization, equipment installation support, and qualification readiness.
  
• Operate, maintain, and troubleshoot a broad range of primary container and analytical laboratory equipment, including:
  
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  • Leak detection systems
    
  • Headspace analyzers
    
  • Optical and particle counting microscopes
    
  • MicroCT scanners
    
  • Automatic filling equipment
    
  • Filtration and mixing tanks
    
  • Balances and related instrumentation
    
  
  
  
• Independently refine and develop laboratory processes and equipment workflows to improve efficiency, robustness, and usability.
  
• Maintain accurate equipment logs, calibration records, and instrument readiness documentation.
  
• Ensure laboratory organization, including consumables tracking, chemical inventory, and compliance with safety, quality, and documentation requirements.
  
• Partner with Facilities, Metrology, EH&S, and cross-functional Process Development teams to support seamless lab operations and timely issue resolution.
  

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• Apply sound scientific judgment in planning and troubleshooting experimental studies.
  
• Support method development, workflow optimization, and evaluation of new technologies relevant to primary container development and characterization.
  
• Drive continuous improvement in lab workflows, equipment utilization, and operational efficiency.
  
• Maintain a culture of cleanliness, organization, and scientific excellence within the laboratory.
  

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• Bachelor's or Master's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
  
• Hands-on laboratory experience (academic or industry) with strong familiarity in equipment operation and laboratory best practices.
  
• Demonstrated experience designing and executing experiments with strong attention to detail and scientific rigor.
  
• Excellent organizational skills with a proven ability to maintain a clean, structured, and efficient laboratory environment.
  
• Strong communication skills and ability to manage multiple priorities in a fast-paced environment.
  

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• Experience supporting laboratory setup, including equipment installation, qualification, and initial operational readiness.
  
• Familiarity with a broad range of laboratory equipment, including routine operation, troubleshooting, and maintenance.
  
• Experience with studies involving:
  
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  • Container Closure Integrity (CCI)
    
  • Extractables and Leachables
    
  • Device-drug interface evaluations
    
  • Fill-finish operations
    
  
  
  
• Ability to design and refine lab workflows that improve efficiency and usability across teams.
  
• Prior experience working within cross-functional development teams.
  

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• M.S. in biochemical/chemical engineering or life sciences related disciplines with 2+ years of industrial experience; or B.S. in biochemical/chemical engineering or life sciences related disciplines with 5+ years of industrial experience.
  
• Excellent interpersonal and communication skills. Strong scientific curiosity with a passion for problem-solving and optimization. Self-motivated with excellent attention to detail and ability to multi-task. Strong organizational, planning and trouble-shooting skills.
  
• Understanding of cell culture processes (e.g., cell culture process development, process scale up and scale down, recombinant protein production, protein characterization).
  
• Proven experience working aseptically in cell culture processes at benchtop bioreactor scale.
  
  Key Responsibilities:
  
  * Execute scientific research and development to significantly improve platform processes and workflows, develop new methods, build technical expertise and intellectual property, and deepen scientific understanding.
  
  * Work collaboratively and cross-functionally with colleagues in other functional areas (Analytical Development, Cell Line Development, Discovery, Manufacturing and Quality).
  
  * Proactively seek out new information and opportunities to advance our technologies and pipeline. Critically evaluate relevant scientific, regulatory and business advances and integrate this knowledge.
  
  * Effectively communicate scientific data and concepts to internal and external audiences through reports, presentations and manuscripts. Author and review technical reports, protocols, and other key documents.
  
  * Understand and adhere to corporate standards regarding code of conduct, safety, documentation and GMP compliance.
  
  Qualifications:
  
  * M.S. in biochemical/chemical engineering or life sciences related disciplines with 2+ years of industrial experience; or B.S. in biochemical/chemical engineering or life sciences related disciplines with 5+ years of industrial experience.
  
  * Excellent interpersonal and communication skills. Strong scientific curiosity with a passion for problem-solving and optimization. Self-motivated with excellent attention to detail and ability to multi-task. Strong organizational, planning and trouble-shooting skills.
  
  * Understanding of cell culture processes (e.g., cell culture process development, process scale up and scale down, recombinant protein production, protein characterization).
  
  * Proven experience working aseptically in cell culture processes at benchtop bioreactor scale.
  

Open date: February 26, 2026

Next review date: Thursday, Mar 12, 2026 at 11:59pm (Pacific Time)

Apply by this date to ensure full consideration by the committee.

Final date: Saturday, Mar 28, 2026 at 11:59pm (Pacific Time)

Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled.

The Advanced BioImaging Center (ABC) in the Department of Molecular and Cell Biology at the University of California, Berkeley seeks applications for a Professional Researcher at the Assistant, Associate, or Full rank. The selected candidate will be appointed at the rank to commensurate with prior experience. The position will report to Professor Gokul Upadhyayula, with Professor Eric Betzig serving as an additional academic mentor. The researcher will conduct independent research at a level comparable to the Professor series.

The Advanced BioImaging Center (ABC) at UC Berkeley aspires to be a world-leading multidisciplinary imaging center that drives important biological discoveries through critical new advances in all aspects of imaging technology and that drives the dissemination of that technology through a multi-pronged education strategy to scientists around the world. ABC was intentionally designed to maximize scientific productivity and impact by adopting groundbreaking imaging technologies such as the next-generation adaptive optical multifunctional microscope, incorporating the high-level technical expertise of instrumentation scientists, applied mathematicians, and computational scientists, and building worldwide collaborations aimed at tackling the challenges posed by terabyte and petabyte-scale imaging data processing, visualization, and dissemination. Members of the ABC have access to leading - edge imaging and computing hardware, as well as exposure to collaborators from a range of diverse disciplines, including in the fields of Artificial Intelligence, Data Science, Mathematics, and more.

This position will focus on advanced, independent research leading the ABC computational team to develop vision-transformer-based foundation machine learning models. The Researcher will work closely with an interdisciplinary team of optical physicists, engineers, and computational imaging researchers to achieve the ambitious goal of creating a generative AI model for segmenting and querying complex 4D high-resolution data of zebrafish development. This is an exciting opportunity to contribute to advancing biological imaging and AI-driven data analysis at the intersection of biology and computational science.

As this project grows, the individual will be expected to expand their leadership and adapt to the evolving scope of the research. The role will begin with leading efforts to supervise data collection and management, model development, and collaborating with leadership across the center. The researcher will build and manage a team of data scientists, and computational biologists to test AI-driven imaging models and will facilitate scientific collaborations with local, domestic, and international researchers. This position will take on a growing role and contribute to a groundbreaking initiative in biological imaging.

Key Responsibilities:

*Conduct and design independent research and lead a team of data scientists and software engineers to enable the development of state-of-the-art AI models for light sheet microscopy data.

*Collaborate with experts in optical physics, engineering, and computational imaging to support a foundational AI model for high-resolution developmental biology data.

*Conduct and lead experimental design, data acquisition, and data analysis pipelines to ensure optimal data quality.

*Facilitate and maintain scientific collaborations with local, domestic, and international researchers as the project expands.

*Publish research findings in high-impact journals and presenting at scientific conferences.

*Supervise and mentor graduate students, postdoctoral fellows, staff scientists, and academic research titles involved in machine learning and biological data analysis.

*Lead the development of new AI models and data processing tools for datasets generated on multicellular tissues, organoids, transparent embryos.

*Oversee the design and development of new machine learning tools for petabyte-scale light sheet datasets that are typically 4D or 5D (x,y,z,t,chemistry).

*Advise on applications of these tools for biological imaging; collaborate with graduate students, postdoctoral fellows and academic research titles on specific projects to test, learn and implement for general and specific use cases.

*Bring cross disciplinary expertise to solve problems at the intersection between life science, computer vision, and state-of-the-art AI methods.

*Identify and study scaling laws for machine learning models on large-scale 5D light sheet datasets.

*Organize and plan on the design and development of new AI techniques to further ABC's mission.

Lab:

PhD (or equivalent international degree)

Two (2) years of post PhD research experience.

For consideration for Associate Researcher rank, a minimum of 8 years of post PhD research experience as a group leader or principal investigator (PI) supervising a team of PhD-level scientists in industry or academia.

For consideration for full Researcher rank, a minimum of 14 years post PhD research experience, including a minimum of 8 years of experience leading a team as a principal investigator (PI) at the university level or in industry with demonstrated success managing graduate students, postdoctoral researchers, technicians, or equivalent positions.

*PhD or equivalent international degree in Data Science, Computer Science, Bioinformatics or Related field.

*Hands-on experience with developing machine learning models for large-scale light sheet microscopy.

*Strong publication record indicating research independence and leadership.

*Excellent communication, organizational, and leadership skills.

*Proven track record of interdisciplinary collaboration, especially in integrating machine learning with biological research, physics, engineering, or computational fields.

*Demonstrated experience working with large-scale biological datasets, including experience with computational image analysis.

*Demonstrate understanding of optical microscopy, including light sheet microscopy, adaptive optics, and modern scientific cameras.

*Demonstrated ability to work in a research team, manage active collaborations with other academic groups.

*Demonstrated experience handling and processing large scale imaging datasets (>100TB to petabyte scale and beyond).

*Expertise in programming in C/C++, MATLAB, Bash.

*Expertise in databases, data infrastructure, data governance.

*Expertise in high performance computing using SLURM or LSF.

*Experience with PyTorch, JAX, or Tensorflow.

*Experience with NVIDIA CUDA and related OpenMP programming.

*Experience with cloud services (AWS, GCP, Azure, etc.).

*Experience with state of the art AI/ML architectures (vison transformers, diffusion models, etc.).

*Experience supervising and mentoring undergraduate/graduate students, and/or technicians.

*Ability to effectively communicate, participate in efficient and open collaboration, and engage with a diverse group of researchers.

*The ideal candidate will be innovative and able to synergize various ideas and approaches, while exercising sound judgment to evaluate and take acceptable risks.

*Expertise in leading teams in executing machine learning projects, as evidenced by last author peer-reviewed publications within their scientific discipline.

*Readiness to scale efforts and grow with the expanding scope of the project, including building and managing a team and facilitating collaborations.

• Curriculum Vitae - Your most recently updated C.V.

  
  

• Cover Letter

  
  

• Research Statement - Please discuss research accomplishments and proposed plans. This can include, for example, your publication record, awards, presentations, inclusive research practices that promote the excellence of your research, and areas for future research.

  
  

• 3 required (contact information only)

Help contact:

UC Berkeley is committed to diversity, equity, inclusion, and belonging in our public mission of research, teaching, and service, consistent with UC Regents Policy 4400 and University of California Academic Personnel policy (APM 210 1-d). These values are embedded in our Principles of Community, which reflect our passion for critical inquiry, debate, discovery and innovation, and our deep commitment to contributing to a better world. Every member of the UC Berkeley community has a role in sustaining a safe, caring and humane environment in which these values can thrive.

The University of California, Berkeley is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.

For more information, please refer to the University of California's Affirmative Action and Nondiscrimination in Employment Policy and the University of California's Anti-Discrimination Policy.

In searches when letters of reference are required all letters will be treated as confidential per University of California policy and California state law. Please refer potential referees, including when letters are provided via a third party (i.e., dossier service or career center), to the UC Berkeley statement of confidentiality prior to submitting their letter.

As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.

Unless stated otherwise, unambiguously, in the position description, this position does not include sponsorship of a new consular H-1B visa petition that would require payment of the $100,000 supplemental fee.

As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct.

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• "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment or discrimination, as defined by the employer.
  
• UC Sexual Violence and Sexual Harassment Policy
  
• UC Anti-Discrimination Policy
  
• APM - 035: Affirmative Action and Nondiscrimination in Employment
  

Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with our customers, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with.
In the USA, we develop, market and produce a wide array of solutions from our 25 most innovative sites, based across the country. Stretch your skills, create and get inspiration from passionate colleagues. Every day, your energy, your thirst for knowledge, and your creativity will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature.

Givaudan's Flavors Science & Technology department is looking for a Molecular Pharmacologist to join our versatile team and promote the latest flavor ingredient discovery. You will use your knowledge in molecular biology, receptor pharmacology, and advanced biological assay techniques to support flavor ingredient discovery from screening through lead optimization. Working with cheminformatics, chemistry, natural products, and sensory teams, you will help solve important challenges in taste modulation through rigorous, data-driven science.

Title:Molecular Pharmacologist

Department:Givaudan Flavors Science & Technology

Location: Cincinnati, Ohio

Reporting To:Flavors Science & Technology Leadership

Responsibilities

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  Provide insight and lead in vitro biology assay development to support flavor ingredient discovery programs, from screening to lead optimization

  
  
  

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  Guide in vitro biology strategies for exploratory and early-stage discovery efforts

  
  
  

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  Manage experimental design, development, and implementation of cell-based assays for small molecule discovery projects

  
  
  

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  Apply advanced biological assay techniques to discover and develop novel flavor ingredients

  
  
  

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  Oversee review, analysis, and interpretation of in vitro data

  
  
  

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  Translate experimental results to improve understanding of taste and olfaction and elucidate how receptor-active substances modulate sensory endpoints.

  
  
  

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  Collaborate with researchers in cheminformatics, chemistry, natural products, and sensory teams

  
  
  

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  Collaborate with functional experts toidentifynovel research approaches supporting long-term strategic targets

  
  
  

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  Build andfacilitatecollaborations with academic partners, CROs, universities, and the broader Givaudan scientific network

  
  
  

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  Mentor junior scientists in developing skills essential for rigorous research execution

  
  
  

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  Present research findings through peer-reviewed publications, scientific meetings (talks and posters), and internal presentations

  
  
  

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  Represent research programs to Givaudan leadership

  
  
  

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  Ensure all research and discovery activities meet the highest quality, ethical, regulatory, QC, and compliance standards

  
  
  

Your Professional Profile Includes

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  PhD in Molecular Pharmacology

  
  
  

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  2-3 years of experience in pharmaceutical or biotechnology industries; alternatively, 2-3 years of postdoctoral research focused on GPCRs

  
  
  

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  In-depth knowledge of receptor pharmacology with practical experience working with GPCRs

  
  
  

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  3+ years of experience with cell-based techniques including Fluorescence Imaging, HTRF,NanoBRET, Tag-Lite, andAlphaScreen

  
  
  

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  Expertisein the development of in vitro biological assays supporting small-molecule discovery programs

  
  
  

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  Experience using AlphaFold and Cryo-EM 3D structural models to interrogate GPCRpharmacology ishighly desirable

  
  
  

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  Demonstrated scientific rigor in critically reviewing data and independently formulating and testing novel scientific hypotheses

  
  
  

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  Demonstrate a scientific approach grounded in creativity and data-driven decision-making.

  
  
  

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  Communicate complex scientific concepts to team members.

  
  
  

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  Experience managing external studies at CROs or universities (desirable)

  
  
  

Compensation and Benefits

The established salary range for this position is $96,000-$130,000. Actual compensation will depend on individual qualifications. Medical, dental, and vision coverage and a high-matching 401(k) retirement plan.

#LinkedIn

At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives.
You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions.
Every essence of you enriches our world.
Diversity of perspectives fuels innovation and fosters deeper connections with our employees, customers, and partners. At Givaudan, we are dedicated to cultivating an inclusive environment where every individual's voice is valued and has the power to shape our world. Join us in making a difference together.

• 
  
• Plan and execute assigned on-site experiments in support of Process Development activities and project goals.
  
• Select appropriate experimental methods and techniques based on project requirements.
  
• Analyze and interpret experimental data, evaluate data quality, and identify anomalous results.
  
• Recommend alternative approaches, research new methods and techniques, and proactively consult senior team members to resolve technical challenges.
  
• Participate in group meetings and present experimental results, data interpretation, and conclusions.
  
• Demonstrate strong verbal communication and interpersonal skills, including the ability to clearly explain experimental processes and outcomes.
  
• Work collaboratively with a team-oriented, problem-solving mindset.
  
• Consistently follow safety practices; ability to work with highly potent compounds upon appropriate training.
  

• 
  
• Bachelor's or higher degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, or a related scientific discipline.
  
• Prior experience in biologics purification, with emphasis on conjugation, tangential flow filtration (UF/DF), and filtration.
  
• Experience with analytical techniques such as SEC/HPLC, capillary electrophoresis (reducing/non-reducing), and HCP testing is beneficial but not required.
  
• Knowledge of cGMPs, technology transfer, and bioprocess scale-up.
  
• Strong technical writing skills.
  
• Ability to work effectively in cross-functional and multidisciplinary teams.
  
• Working knowledge of downstream process development, including centrifugation, normal and tangential flow filtration, chromatography operations, and virus clearance, with hands-on experience in several areas expected.
  
• Experience with multiple biologic modalities (e.g., monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates, virus particles) and expression systems (microbial and mammalian) is a plus.
  
• Ability to design and execute purification experiments with increasing independence to support process definition, optimization, and characterization.
  
• Collaborate with Technical Operations during technology transfer from process development to GMP manufacturing, including on-floor support, troubleshooting, and identification of process and equipment improvements.
  
• Contribute to regulatory filings, process validation, and characterization reports.
  
• Self-motivated, well-organized, and intellectually curious, with interest in scientific literature and conferences.
  

• 
  
• BS degree in a relevant scientific discipline with 2+ years of relevant experience, OR
  
• MS degree in a relevant scientific discipline with 0+ years of relevant experience
  

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.

Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.

• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.

• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.

• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.

• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.

• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.

• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.

• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.

• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.

• Support process development activities during technology transfer.

• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.

• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

• Review MBRs daily to ensure documentation is accurate and complete.

• Participate in audits, inspections, qualifications, and validation activities.

• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.

• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

• Exceptional attention to detail with a strong commitment to quality standards.

• Excellent collaboration, communication, and interpersonal skills.

• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.

Preferred Qualifications

• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.

• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.

• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.

• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).

Physical Requirements

• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.

• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.

• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be comfortable working with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.

Position Overview

We are seeking an innovative and dynamic AI/ML Research Senior Scientist with a passion for leveraging AI/ML in antibody discovery and design to join our Large Molecule AI/ML team. This role will be part of a multidisciplinary team focused on integrating advanced computational methods with cutting-edge experimental strategies to drive breakthrough discoveries in large molecule therapeutics and deepen our understanding of disease biology. The ideal candidate will have a strong background in computational biology, machine learning, and structural modeling and specifically with the application of AI/ML in biologics discovery.

Key Responsibilities

• Develop and implement state-of-the-art AI/ML methodologies for de novo antibody design and discovery, including fine-tuning protein language models and generative protein design.
• Develop, implement, and deploy advanced machine learning algorithms for the multi-objective optimization of antibodies, antigens, ADCs, and other biologics.
• Build tools to incorporate data from integrated Design-Predict-Make-Confirm cycles with automated experimental platforms generating quality data at scale needed for project-specific and foundational models.
• Innovate, develop, and apply predictive models for protein design and developability engineering, utilizing large-scale NGS, in vitro, in vivo and other proprietary in-house and external data sources.
• Manage and process large-scale biological datasets for model training and evaluation
• Stay abreast of advancements in NLP, ML, and generative AI to build novel tools that enhance therapeutic discovery and development.
• Collaborate with internal experts to optimize the computational discovery infrastructure, offering both individual and team-based innovative solutions.
• Communicate complex scientific ideas effectively to both technical and non-technical audiences, fostering collaboration across multidisciplinary teams.

Qualifications

• PhD degree in a scientific discipline (or equivalent) with 2+ years relevant experience, or MS with 8+ years relevant experience, or BS with 10+ years relevant experience
• Proven track record in developing machine learning models for chemical and biological data, including AI/ML-enabled molecular generation and affinity prediction.
• Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction.
• Proficiency in programming languages such as Python and experience with cloud computing capabilities.
• Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute individually and collaboratively.
• Versatile communicator who can elucidate complex ideas to non-specialists and commitment to continuous improvement and innovation.
• Demonstrated learning agility, and scientific curiosity while maintaining focus on driving greater impact in the face of uncertainty and change.
• Strong problem-solving aptitude and strategic thinking with an entrepreneurial mindset.

Preferred Qualifications & Skills:

• Experience developing or applying modern ML architectures for antibody design models (LLMs, diffusion models, flow-matching, Bayesian Optimization, GNNs, etc.)
• Experience designing de novo binders for specified targets and epitopes
• Experience analyzing NGS-derived antibody repertoires for sequence- and structure-based design
• Experience with molecular simulation and conformational analysis techniques

ADDITIONAL INFORMATION

• The position will be based in Cambridge, MA

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Worker Type

Worker Sub-Type

Time Type

Job Exempt

Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with our customers, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with.
In the USA, we develop, market and produce a wide array of solutions from our 25 most innovative sites, based across the country. Stretch your skills, create and get inspiration from passionate colleagues. Every day, your energy, your thirst for knowledge, and your creativity will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature.

Givaudan Flavors Science & Technology is looking for a Cheminformatics Scientist to join a versatile team advancing flavor ingredient discovery. You will apply cheminformatics, machine learning, and AI to develop novel aroma and taste molecules while collaborating across research teams to build data-driven discovery workflows.

Your Title: Cheminformatics Scientist

Your Location: Onsite (Givaudan facility)

You Will Report To: Flavors Science & Technology Computational Sciences Lead

Responsibilities

• 
  
• Design and implement cheminformatics algorithms and workflows to accelerate flavor ingredient discovery across aroma and taste modalities.
  
• Develop, validate, and deploy predictive models using QSAR, machine learning, artificial intelligence, and 2D/3D computational approaches for small-molecule analysis and property prediction.
  
• Apply statistical, cheminformatics, and machine learning methods to improve hit identification and hit-to-lead processes.
  
• Collaborate with chemistry and research teams to integrate AI/ML and cheminformatics into DMTA workflows.
  
• Enhance databases and computational pipelines to support data-driven research.
  
• Develop computational tools, visualizations, and analytical programs for molecular data analysis.
  
• Communicate scientific insights across teams and support collaboration.
  
• Provide mentoring and promote best practices in data integrity, reproducibility, and FAIR data principles.
  

Your Professional Profile Includes

• 
  
• PhD or Master's degree in Cheminformatics, Computational Chemistry, Chemistry, or a related discipline.
  
• Expertise in structure-based drug design (SBDD), including docking, pharmacophore modeling, virtual screening, and molecular dynamics.
  
• 3+ years of experience with ligand-based modeling (QSAR, 2D/3D virtual screening) and protein modeling (e.g., homology modeling, protein-protein docking).
  
• Data science and statistical analysis skills, including exploratory data analysis and model validation.
  
• Advanced programming skills in Python or R, plus proficiency in an additional language, following coding best practices.
  
• Experience with cheminformatics tools (e.g., RDKit, OpenEye) and molecular analysis techniques such as library enumeration, similarity analysis, clustering, and dimensionality reduction.
  
• Industry familiarity with SQL/databases, analytics tools (KNIME, Spotfire, Shiny), and NLP/LLMs in scientific contexts; relevant industry experience.
  

Compensation and Benefits

The established salary range for this position is $80,000-120,000k, depending on individual qualifications and experience. Employees receive medical, dental, and vision coverage, along with a high-matching 401(k) retirement plan.

#LI-Onsite

At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives.
You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions.
Every essence of you enriches our world.
Diversity of perspectives fuels innovation and fosters deeper connections with our employees, customers, and partners. At Givaudan, we are dedicated to cultivating an inclusive environment where every individual's voice is valued and has the power to shape our world. Join us in making a difference together.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you

We are seeking a Senior Scientist to lead the design and implementation of AI orchestration systems within the AI/ML Foundation team. This role combines expertise in agentic AI systems, data engineering, and software architecture to build the infrastructure that enables seamless coordination of AI capabilities across Computational Sciences and Global Research. You will be responsible for creating intelligent orchestration layers that connect diverse AI models, data pipelines, and computational resources to accelerate drug discovery across all therapeutic modalities. The ideal candidate brings strong engineering fundamentals with experience in distributed systems and a passion for building scalable AI platforms.

Accountabilities:

• Design and implement AI orchestration frameworks that integrate agentic systems, data pipelines, and model serving infrastructure to enable coordinated multi-model workflows.
• Build scalable orchestration layers connecting predictive models, generative models, and foundation models with experimental data sources for end-to-end workflow automation.
• Develop data engineering solutions including data ingestion pipelines, transformation workflows, feature stores, and model serving infrastructure supporting discovery across modalities.
• Create intelligent orchestration systems that coordinate agentic AI components for autonomous task decomposition, tool selection, and execution across scientific domains.
• Establish monitoring, observability, and governance frameworks ensuring reliability, reproducibility, and transparent decision-making across AI systems.
• Partner with computational scientists, data engineers, and research teams to ensure orchestration infrastructure meets the needs of diverse discovery workflows.
• Stay current with advances in agentic AI, workflow orchestration, and distributed systems; evaluate and integrate emerging technologies.

Education & Requirements:

• PhD in Computer Science, Data Engineering, Computational Science, or related field with 2+ years relevant experience, OR MS with 6+ years relevant experience.
• Strong software engineering skills with proficiency in Python and experience with distributed systems and cloud infrastructure (AWS, GCP).
• Experience with workflow orchestration frameworks (Airflow, Prefect, Dagster, or similar) and data pipeline development.
• Familiarity with agentic AI frameworks (LangChain, AutoGen, or similar) and LLM integration patterns.
• Experience with containerization (Docker, Kubernetes) and microservices architecture.
• Strong problem-solving skills and ability to work across teams in a fast-paced R&D environment.

Preferred:

• Experience building AI/ML platforms or infrastructure in pharmaceutical or life sciences settings.
• Familiarity with scientific computing workflows and computational chemistry/biology tools.
• Experience with model serving frameworks (TorchServe, Triton, BentoML) and feature stores.
• Knowledge of monitoring and observability tools (Prometheus, Grafana, MLflow).
• Experience with event-driven architectures

Additional Competencies Common in Strong Candidates

• Ability to lead cross-functional initiatives and mentor junior scientists.
• Experience in translating computational insights into experimental strategies.
• Strong publication record or demonstrated thought leadership in AI for biology and molecular design.
• Comfort working in fast-paced, innovation-driven environments with evolving priorities.

ADDITIONAL INFORMATION

• The position will be based in Cambridge, MA

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Worker Type

Worker Sub-Type

Time Type

Job Exempt

Principal Scientist, Botanical Identification & Authentication

Location: Ann Arbor, MI

Schedule: Full-Time, On-Site

Compensation: Top-of-market salary + equity + full benefits

About the Opportunity

A venture-backed laboratory technology company is building a modern testing platform designed to make product safety, purity, and ingredient verification faster, more transparent, and easier for consumer brands.

Backed by leading investors and experienced founders, the company is rethinking how laboratory testing integrates with software—allowing brands to streamline regulatory compliance while using testing data to build consumer trust.

As part of its next phase of growth, the company is launching a Botanical Identification & Authentication division and is seeking a Principal Scientist to build and lead this capability from the ground up.

This is a greenfield leadership opportunity for a scientist who has previously built or led botanical authentication programs and wants to architect a best-in-class system using modern lab infrastructure and scalable processes.

Role Overview

The Principal Scientist, Botanical Identification & Authentication, will design, build, and scale a comprehensive botanical identity testing program.

This role will be responsible for method selection, validation, SOP development, reference library creation, and production-scale testing workflows. You will also serve as the organization's technical authority on botanical identification, helping internal teams and customers navigate complex ingredient authentication challenges.

The ideal candidate combines deep technical expertise with systems thinking, capable of building a rigorous and scalable authentication framework that integrates multiple orthogonal testing methods.

Key Responsibilities

• Build the company's botanical identification and authentication program, including instrumentation selection, testing menu design, and operational workflows.
• Develop multi-method authentication strategies incorporating techniques such as:
• HPTLC
• Macroscopic and microscopic botanical identification
• DNA barcoding
• Chemical profiling and fingerprinting
• Establish and curate botanical reference libraries, including voucher specimens, chromatographic fingerprints, DNA barcode sequences, and microscopic image datasets.
• Develop SOPs, validation protocols, and documentation frameworks that support repeatability, regulatory alignment, and scalable operations.
• Lead method development and validation efforts aligned with recognized pharmacopeial and botanical testing standards.
• Serve as the organization's technical authority on botanical identity determinations, helping resolve ambiguous or disputed identifications.
• Train and mentor laboratory staff on botanical authentication techniques to build internal expertise.
• Partner with laboratory leadership and executive teams to prioritize method development and align testing services with customer demand.
• Drive continuous improvements in turnaround time and testing efficiency, applying automation and process optimization where possible.
• Stay current on emerging technologies and regulatory developments in botanical authentication.

Qualifications

Education & Experience

• PhD or MS in Botany, Pharmacognosy, Plant Biology, Natural Products Chemistry, or a related field
• 10+ years of hands-on experience in botanical identification and authentication
• Prior experience building or managing a botanical identity testing program, ideally within an analytical or contract testing laboratory

Technical Expertise

• Deep expertise in:
• HPTLC method development and interpretation
• Microscopic and macroscopic botanical identification
• DNA barcoding for species identification
• Experience designing orthogonal authentication strategies using multiple analytical techniques
• Proven experience taking laboratory methods from development through validation and routine production use

Regulatory & Industry Knowledge

• Familiarity with pharmacopeial standards and botanical testing methods
• Working knowledge of dietary supplement and botanical regulatory frameworks
• Experience with quality systems such as ISO 17025 is preferred

Additional Attributes

• Systems thinker with the ability to design scalable laboratory processes
• Strong communicator capable of translating complex scientific concepts into clear guidance
• Comfortable working in a fast-paced, high-growth environment

Compensation & Benefits

• Top-of-market salary
• Equity participation
• Health, dental, and vision insurance
• Paid time off and holidays
• Opportunities for long-term career growth within a rapidly scaling organization

Why This Role

This is a rare opportunity to build a botanical authentication capability from the ground up within a modern laboratory platform backed by experienced founders and strong venture funding.

The team is focused on bringing greater transparency and scientific rigor to consumer products, helping companies verify product integrity while meeting evolving regulatory requirements.

If you're excited about combining deep botanical science with real-world impact, we'd love to connect.

About the Role

Kolon TissueGene, Inc. is seeking an Associate Director, Clinical Quality Assurance responsible for maintaining the Quality Management System and other programs to support Clinical Operations and commercialization of biopharmaceutical products. This role will ensure that all Clinical QA details are managed efficiently and exhibit continuous improvement.

Reporting to the Head of Quality Assurance, this role will support Inspection Readiness, regulatory Inspections, Quality policies and procedures. The Associate Director, Quality Assurance will work with Clinical Operations and Regulatory Affairs to ensure adherence to KTG policies, programs, and procedures in support of commercialization. A fundamental measure of success for the position will be a successful BLA Approval Inspection and launch of commercialized drug products.

This position is based on-site at our Rockville, Maryland headquarters.

Key Responsibilities

Quality Systems Leadership

• Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including Change Control, Deviations, Complaints, Vendor Management, and Audit programs.
• Ensure quality processes and systems meet FDA and global regulatory expectations.
• Oversee electronic quality systems supporting training management and GxP document control.

Clinical Quality Oversight

• Drive the GCP Quality strategy across clinical development programs.
• Provide independent Quality oversight of Clinical Operations to ensure compliance with regulatory and internal quality requirements.
• Review and approve clinical and nonclinical documentation, including protocols, amendments, deviations, CAPAs, and change controls.
• Oversee the development and maintenance of Clinical SOPs.
• Manage training qualification and compliance for Clinical Operations and Data Management teams.

Inspection Readiness & Regulatory Support

• Lead inspection readiness activities across clinical programs.
• Serve as a lead representative during FDA inspections and vendor audits.
• Support regulatory interactions including GCP inspections, Pre-Approval/BLA inspections, and investigator site inspections.
• Ensure clinical programs maintain inspection-ready documentation and processes.

Risk Management & Continuous Improvement

• Lead quality risk management initiatives, facilitating risk assessments and implementing mitigation strategies.
• Identify opportunities for process improvements and quality system enhancements.
• Ensure quality initiatives and projects are properly resourced and executed within established timelines.

Leadership & Team Development

• Build and lead a high-performing Clinical QA team.
• Manage hiring, coaching, and development of Quality staff.
• Promote a culture of quality, compliance, and “first-time-right” execution.
• Ensure team members maintain appropriate training and qualifications.

Operational & Strategic Support

• Develop and manage Quality department timelines, budgets, and resource planning.
• Provide regular updates to senior leadership and project teams regarding Clinical QA activities and inspection readiness.
• Manage Quality vendor relationships and contracts, including quality consultants and electronic quality system providers.

Qualifications

Education

• Bachelor’s degree in Biological Sciences, Life Sciences, Physical Sciences, or a related discipline required
• Advanced degree (M.S., Ph.D., or equivalent) preferred

Experience

• 10+ years of experience in the biopharmaceutical industry, with a minimum of 8 years demonstrated experience of direct interaction with FDA and other regulatory agencies through GCP, Pre-Approval/BLA Inspections, and Investigator Site inspections.
• 6+ years of leadership experience in Clinical Quality Assurance roles
• Experience developing, implementing, and maintaining Quality Management Systems (QMS)
• Experience working with Clinical Operations and Regulatory Affairs teams in regulated development environments
• Experience in cell and gene therapy programs or advanced biologics preferred

Core Competencies

• Strong knowledge of ICH guidelines, FDA regulations, and GCP compliance requirements
• Expertise in Quality Management Systems, including change control, deviations, CAPA, audits, and vendor oversight
• Ability to maintain independent Quality oversight of Clinical Operations
• Strong leadership, organizational, and team development skills
• Excellent written and verbal communication skills
• Strong problem-solving and risk management capabilities
• Demonstrated commitment to quality, compliance, and continuous improvement

Work Environment & Physical Requirements

• On-site position with up to approximately 20% travel.
• Extensive computer and keyboard use involving repetitive motion.
• Regular telephone and in-person communication.
• Ability to lift up to 25 pounds, with or without reasonable accommodation.

Kolon TissueGene will provide reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state law.

Why Join Kolon TissueGene?

Kolon TissueGene is advancing innovative regenerative cell and gene therapies designed to address the root causes of disease. As a member of our Bioinformatics team, you will contribute directly to the scientific rigor and data integrity that enable safe, effective therapies to reach patients.

About Us

Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company developing first-in-class regenerative therapies, including TG-C for osteoarthritis of the knee. We are building a mission-driven team committed to scientific excellence, regulatory compliance, and patient impact.

Benefits Highlights:

• Onsite yet Flexible work schedules
• Premium-free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• Long-term incentive bonuses
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities
• Visa sponsorship available for qualified candidates

Equal Opportunity Employer

Kolon TissueGene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

Apply today to shape the future of regenerative medicine with precision, rigor, and purpos

Title - QC Analyst I (Stability Study Coordinator I)

Duration - 9 Months (Possibility of extension)

Location - Vacaville CA

Summary

With limited supervision, QC Stability Study Coordinator, is responsible for the oversight of stability program management in accordance with cGMP regulations. These duties include execution of trend analysis, documentation review, support of deviations (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Stability Study Coordinator works to meet departmental and organizational goals.

Job Responsibilities

Review data and assess against established acceptance criteria

Perform technical review of peer-generated data

Evaluate data to identify trends and/or establish limits

Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed

Identify and troubleshoot technical problems

Identify gaps in systems and procedures

Receive training

Support the maintenance and compliance of operational areas

Assure and apply GMP throughout operations

Coordinate with customers to support multi-site operational activities

Support internal and external audits and regulatory inspections

Works to meet schedules, timelines, deadlines

Participate in and/or lead group and project teamwork; project and process improvements

Stability Protocol Creation

Stability deviation assessments

Routine Master Data Testing Creation

Routine Master Data Testing Review

Routine and non-routine Out Of Trend linear regression assessments.

Annual Product Quality Reviews (APQRs) - Author assistance develop to authoring

Time Point Approval assistance

Change control of various documents

Data / Data Table requests / annual report requests (non-routine requests) (e.g.,

Client monitor requests)

Actively participate in various stability related projects

Data entry and review

Assist with training coordination

Assist with Perform other duties as requested by managers to support Quality activities

Job Requirements

B.S. /B.A. degree and 1-3 years of experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.

Strong verbal and written communication skills, ability to organize and present information both formally and informally.

Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.

Routinely exercises sound judgment, reasoning and problem solving.

Capable of working under limited supervision and determining own short term priorities.

Essential Functions of the job:

• Review and validate QC data and test records.
• Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results.
• Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory.
• Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards
• Undertake other duties as required.

This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.

Education/Experience Required:

• Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
• Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Strong working knowledge with USP/EP and cGMP/EU GMP.
• Technical writing experience.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development
• Self-motivated, with the ability to work proactively using own initiative.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

The role:

The Quality Control Scientist is responsible for execution and oversight of analytical, microbiological, and environmental testing to ensure the safety and quality of cell therapy products and manufacturing operations. The role includes performing GMP testing to support development, donor screening, in-process control, product release, stability, raw material release, and environmental monitoring in accordance with Standard Operating Procedures (SOPs). The QC Scientist serves as a technical resource for analytical methods such as flow cytometry and other cell-based assays, supports assay and equipment qualification, and ensures data integrity and regulatory compliance. Additional responsibilities include authoring or revising procedures, leading continuous improvement initiatives, supporting investigations, contributing to assay development efforts, and train staff as needed.

In the role you will:

• Perform analytical, microbiological, and environmental testing in support of development, donor-screening, in-process control, product release, stability, and raw-material release in accordance with SOPs and GMP requirements.
• Serve as a technical lead for flow-cytometry–based analytical assays, including instrument setup, compensation, gating strategy, data analysis, and troubleshooting.
• Perform and review cell count assays and evaluate data.
• Support method qualification, validation, and transfer for flow cytometry, cell counting, and other analytical assays; ensure accurate, reproducible data generation.
• Conduct environmental and personnel monitoring of controlled areas, including viable air, non-viable particulates, surface, and gowning monitoring.
• Oversee environmental data entry, review, and trend analysis; evaluate results against alert and action levels and support investigations for excursions or adverse trends.
• Execute and review microbiological assays such as sterility, endotoxin (LAL), bioburden, gram staining, growth-promotion, and conductivity/TOC testing.
• Participate in aseptic process simulation (media-fill) runs; provide on-floor QC support during execution and perform subsequent media incubation, inspection, and documentation.
• Sample, test, and document raw-material results and manage disposition.
• Establish and manage relationships with qualified contract laboratories; oversee external testing activities, ensure timely data delivery, review results, and verify accuracy for inclusion in release documentation.
• Compile, verify, and review analytical and microbiological data to support generation of Certificates of Analysis (CoA) for raw materials, intermediates, and drug-product release.
• Oversight of stability testing for intermediates and product to support shelf-life claims and IND submission.
• Author and revise SOPs, test methods, and data records; contribute to laboratory continuous-improvement initiatives.
• Author and revise technical reports and support IND submissions.
• Support and provide technical input to deviation, OOS, and CAPA investigations, ensuring scientific rationale and data integrity.
• Participate in equipment calibration, qualification, and maintenance programs, and assist in implementation of new or revised analytical methods.
• Train staff in flow cytometry, microbiological methods, and GMP documentation practices.
• Maintain compliance with GMP, data-integrity, and safety requirements, ensuring laboratory readiness for internal and regulatory inspections.
• Provide input to QC metrics and data-trending reports for management review.
• Maintain a flexible schedule to accommodate manufacturing and testing demands, including periodic weekend, holiday, or extended-hour work and off-shift coverage as needed.

Qualifications: About you

• Minimum 4-6 years relevant QC experience in a GMP and cleanroom environment, supporting biologics or cell therapy products.
• Demonstrated proficiency in analytical and microbiological testing, including flow cytometry, cell counting, endotoxin, sterility, and environmental monitoring.
• Proven experience supporting method qualification, validation, and transfer activities.
• Strong understanding of data review, good documentation practices, and data integrity.
• Experience conducting and authoring investigations, CAPA development, and laboratory deviation documentation.
• Experience collaborating cross-functionally with Manufacturing, QA, and Analytical Development teams to support GMP operations.
• Requires Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
• Expertise in flow cytometry, including instrument setup, compensation, gating, and data analysis.
• Experience leading method qualification, transfer, and troubleshooting for analytical and microbiological assays.
• Advanced understanding of aseptic technique and contamination control in GMP cleanroom operations.
• Experience performing or reviewing microbiological assays, including endotoxin (LAL), sterility, bioburden, gram staining and growth-promotion testing.
• Familiarity with environmental and personnel monitoring, including data trending and evaluation against alert/action levels.
• Experience performing or reviewing in-process and release testing for cell-based products.
• Strong knowledge of raw material testing programs, including identity, endotoxin, and bioburden verification.
• Experience coordinating and reviewing external testing with qualified contract laboratories.
• Proficiency in data review, trending, and reporting using paper or electronic based systems.
• Strong understanding and ability for authoring f GMP documentation, investigations, and change controls.
• Ability to train and qualify analysts in technical procedures and GMP compliance.
• Proactive, self-motivated team player who is comfortable working in a dynamic, fast-paced manufacturing setting, working independently with minimal supervision and adapting to changing schedules.

The targeted salary range for this position is $95,000 - $129,600 per year. MiNK is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with MiNK's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.