Css Scientific Careers Jobs in Usa
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Project description
The customer is looking for a JavaFS / Spring / C# / CSS
Responsibilities
Collaborates with leaders, business analysts, project managers, IT architects, technical leads and other developers, along with internal customers, to understand requirements and develop needs according to business requirements
Maintains and enhances existing enterprise services, applications, and platforms using domain driven design and test-driven development
Troubleshoots and debugs complex issues; identifies and implements solutions
Creates detailed project specifications, requirements, and estimates
Researches and implements new technologies to enhance current processes, security, and performance
Supports the development of coding standards and adheres to best practices and security guidelines
Works closely with software architects and technical leads to ensure decisions meet long-term enterprise growth needs"
Skills
Must have
Bachelor's degree in Computer Science, Computer Engineering, Technology, Information Systems (CIS/MIS), Engineering or related technical discipline, or equivalent experience/training
5+ years of experience designing, developing, and implementing large-scale solutions in production environments TOP Skills Required: Java FullStack / focus on Front End
REACT .NET/C# SQL DataFactory UI Skills, Licenses & Certifications
Proficiency in Full Stack Development
Proficiency with the following technologies:
Programming Languages: C# required, PySpark and Python is a plus.
Frameworks: Spring/SpringBoot, FastAPI, .Net Core, .Net Framework
Front End Technologies: CSS, jQuery, AJAX, Hands on experience in Single Page Architectures such as React is required
Source Control: GitHub, Azure DevOps
CICD: GitHub Actions, Azure DevOps
Data management: PostgreSQL, MS SQL
Integration/APIs Technologies: Kafka, REST, GraphQL
Cloud Providers such as Azure
Other Dev Ops Toolchain: Selenium, SonarQube, GitHub, Kibana, New Relic 10. Proficiency in Networking and security concepts: OAuth, VNet Injection, VNet Integration, Private Endpoints, Azure Firewall 1
Proficiency in object-oriented design techniques and principles 1
Proficiency in Development Tools: Visual Studio, Visual Studio Code, SQL Server Management Studio, Azure Data Studio
Ability to concisely convey ideas verbally, in writing, in code, and in diagrams
Ability to work through others by cooperatively sharing responsibilities
Proficiency in Agile methodologies, such as SCRUM
When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.
About Joslin Diabetes Center World-renowned for its deep expertise in diabetes treatment and research, Joslin Diabetes Center is dedicated to finding a cure for diabetes and ensuring that people with diabetes live long, healthy lives. As one of only 18 NIH-designated Diabetes Research Centers in the United States, and affiliated with Harvard Medical School, Joslin is at the forefront of developing and disseminating innovative patient therapies and scientific discoveries globally. Joslin provides highly specialized diabetes care and education to over 20,000 adults and children annually. Its clinical models are recognized as the standard of care for treating diabetes and related complications both in the United States and around the world. The center's team of diabetes educators, including nurses, dieticians, and exercise physiologists, are nationally certified by the American Diabetes Association, ensuring the highest quality of care and education for patients.
The President and Chief Scientific Officer (CSO) will serve as a visionary leader responsible for shaping and advancing the scientific and strategic direction of the Joslin Diabetes Center. This executive role will guide innovative research initiatives, ensuring alignment with organizational goals and maintaining Joslin's position at the forefront of diabetes care and discovery. Working collaboratively with Beth Israel Lahey Health (BILH) and other strategic partners, the President and CSO will foster a high-performance scientific culture that integrates research excellence with business strategy, regulatory integrity, and clinical impact. The President and CSO will also champion Joslin's unique identity and autonomy as an independent center of excellence, while uniting research, clinical and administrative leadership to drive transformative outcomes in diabetes science and care. As part of this role, the President and CSO will also hold an academic appointment as Full or Associate Professor in the Field of Diabetes at Harvard Medical School (HMS), commensurate with experience, training, achievements, and teaching activities. This is a pivotal leadership position which will present the opportunity to shape our scientific vision, drive transformative innovation, and make a meaningful impact across the organization and beyond.
Principal Duties and Responsibilities
- Define and implement the scientific vision and long-term strategic roadmap for Joslin Diabetes Center, aligning research, patient care, and education missions
- Ensure integration with BILH while preserving Joslin's unique identity as an independent center of excellence
- Establish and implement strategic priorities in collaboration with the Joslin Board of Trustees and Senior Leadership Team
- Oversee all core departments, including Research, Clinical Services, Fiscal Services, Fundraising, Commercial Ventures, Quality, and Academia
- Lead, develop, and align executive leadership teams to achieve organizational goals and performance benchmarks
- Ensure compliance with ethical, regulatory, and institutional standards across all scientific activities
- Lead recruitment, retention, and mentorship of high-performing research faculty, scientists, and technical personnel
- Foster interdisciplinary collaboration and oversee cross-functional scientific programs that align with institutional priorities
- Collaborate with the Chief Medical Officer, clinical teams, and BILH leadership to strengthen and integrate patient care initiatives
- Champion quality and safety while supporting alignment with BILH system strategies and Maintaining Joslin's independent clinical and scientific legacy
- Manage financial and strategic commitments from BILH and external stakeholders to support sustained innovation
- Strategically allocate resources to advance scientific objectives and long-term institutional growth
- Drive philanthropic outreach to secure funding for research, innovation, and programmatic development
- Establish external funding pathways through grants, corporate partnerships, and government collaboration
- Align scientific initiatives with enterprise-level business strategy, product development, and innovation goals
- Provide analytical insight and high-level strategic counsel to senior leadership and governing bodies
Key Relationships
- Reports to: Divisional President, Metro Boston BILH and President, Beth Israel Deaconess Medical Center (BIDMC)
- BILH Leadership (for clinical and administrative functions)
- Joslin Board (for research and education strategy and direction)
- Direct reports: Research faculty leaders, Chief Medical Officer, At Joslin: COO, Assistant CFO, VP Philanthropy, Director of Special Projects
- Dotted line relationships with: Chief Academic Officer, BILH
Qualifications
- MD, PhD, or equivalent terminal degree in a relevant clinical or scientific field with a focus on diabetes or endocrinology
- Minimum of 15 years of progressive leadership experience in academic medicine, diabetes research, or integrated health systems
- Proven track record of leading complex, multi-institutional integration initiatives
- Deep understanding of diabetes care delivery, translational research, and academic faculty development, with a specific emphasis on diabetes and related metabolic disorders
- Exceptional interpersonal, strategic, planning, and change management skills, demonstrating the ability to lead and inspire multidisciplinary teams in a dynamic and evolving healthcare environment
Required Competencies
- Leadership and management: Ability to lead and manage a diverse team including direct reports
- Communication: Excellent communication skills to articulate vision, strategy, and goals to various stakeholders
- Analytical Thinking: Strong analytical skills to assess and improve clinical workflows, care delivery models, and research programs
- Innovation: Ability to drive innovation in care delivery, research, and community engagement
- Collaboration: Strong collaborative skills to work effectively with institutional leadership, faculty, and external partners
- Problem-solving: Proactive problem-solving skills to address challenges in integration and care delivery
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions or any other characteristic protected by law.
Pay Range: $350,000.00 USD - $540,000.00 USD The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time In addition to base compensation, this position may be eligible for additional compensation, which may include performance-based incentive bonuses.
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment.
More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.
Equal Opportunity Employer/Veterans/Disabled
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 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 Director, Quality Systems is a hands-on leadership role responsible for leading the development, design, and maintenance of the Quality Management System (QMS). This role will oversee the implementation and continuous improvement of the QMS to maximize efficiency, effectiveness, and compliance with all applicable GxP regulations and client requirements and expectations.
Key Responsibilities
• Develop and maintain the Site Quality Management System and provide ongoing assessment of QMS effectiveness through Quality Management Review (QMR) and other established monitoring programs and processes.
• Identify, execute, and manage quality improvement initiatives to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations and client requirements.
• Support the development of company objectives and ensure Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.
• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.
• Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and inspection readiness strategies.
• Co-lead the Internal Audit program with the Head of Inspection Readiness, including oversight of audit schedules and ensuring appropriate follow-up in alignment with internal procedures, regulatory expectations, client requirements, and auditing best practices.
• Manage the CAPA system, ensuring root causes are clearly identified and addressed through robust corrective actions to prevent recurrence, and that actions are evaluated for effectiveness post-implementation.
• Establish and manage GMP training programs to ensure training requirements align with job functions and job descriptions.
• Collaborate with the Head of Inspection Readiness to coordinate activities related to regulatory and client inspections (announced or unannounced), including preparing documentation, identifying potential compliance gaps, and managing inspection logistics.
• Support post-inspection response activities, including drafting responses, coordinating updates, and ensuring follow-up actions are implemented within the QMS.
• Provide input into regulatory inspection responses to ensure systemic and comprehensive solutions address root causes and prevent recurrence.
Leadership & People Management
• Mentor and coach team members to continually develop and enhance their skills.
• Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.
• Foster a culture of accountability with progressive empowerment and ownership.
• Promote a culture that values innovation, continuous improvement, and personal accountability across the organization.
Required Qualifications
• Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific discipline.
• 10–12 years of cGMP or Quality experience, including prior supervisory or team leadership experience; or a Master’s degree with 5–7 years of relevant experience.
• Experience hosting and managing regulatory and client inspections.
• Strong understanding of Quality Systems requirements and regulatory expectations.
• Excellent oral and written communication, listening, and problem-solving skills.
• In-depth knowledge of regulated activities, health authority expectations, GxP, and Quality Risk Management.
• Strong organizational awareness with significant experience working cross-functionally.
• Experience developing and executing large-scale organizational change initiatives, including change management strategies and planning.
• Demonstrated ability to understand complex processes and facilitate teams toward effective solutions.
• Ability to design and implement global business processes and policies with a strategic and enterprise mindset.
• Proven experience influencing stakeholders across a broad spectrum of GxP topics.
• Flexibility to support varying work schedules, including evenings, weekends, or holidays as needed.
Preferred Qualifications
• In-depth knowledge of cGMP regulations and the ability to apply them in compliance with U.S., EU, and global regulatory standards.
• Experience with cell and gene therapy manufacturing in clinical or commercial environments.
• Strong track record managing quality systems and training programs.
• Expertise in aseptic manufacturing processes.
• Demonstrated ability to foster collaboration, influence cross-functional teams, and drive cultural and operational improvements.
• Innovative mindset with the ability to adapt best practices within a fast-paced, growing organization.
Required Degree
• B.S. in a relevant scientific discipline (advanced degree preferred).
Physical Requirements
Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for aseptic processing facilities, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.
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.
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. Operating from two U.S.-based manufacturing facilities, 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 Director of Manufacturing Science & Technology (MSAT) will lead the technical oversight, process lifecycle management, and technology transfer activities for cell therapy manufacturing programs within a CDMO environment. This role is responsible for ensuring robust, scalable, and compliant manufacturing processes for autologous and allogeneic cell therapy products from clinical development through commercial manufacturing.
The Director will work cross-functionally with Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and Client Program teams to support client programs, drive continuous process improvement, and ensure successful technology transfers into GMP manufacturing.
This role is based in Princeton, NJ and is fully onsite.
Key Responsibilities
• Provide scientific and technical leadership for cell therapy manufacturing processes, including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.
• Serve as the technical subject matter expert (SME) for manufacturing processes supporting client programs.
• Lead troubleshooting efforts and root cause analysis for manufacturing deviations, investigations, and CAPAs.
• Drive implementation of process monitoring and control strategies.
• Lead technology transfer activities from clients or internal process development teams into GMP manufacturing.
• Develop and review technology transfer plans, process descriptions, risk assessments, and gap analyses.
• Ensure successful scale-up and scale-out of manufacturing processes across CDMO facilities, as applicable.
• Oversee continued process verification (CPV) and lifecycle management for manufacturing processes.
• Lead process characterization, comparability studies, and validation support activities.
• Provide real-time technical support to GMP manufacturing operations for clinical and commercial batches.
• Review batch records, deviations, and change controls related to process changes.
• Present technical updates during client meetings and governance reviews.
• Support proposal development, technical due diligence, and onboarding of new client programs.
• Ensure MSAT activities comply with cGMP, FDA, EMA, and ICH regulatory requirements.
• Contribute to regulatory filings, including INDs, BLAs, and comparability packages.
• Support regulatory inspections and client audits.
• Build and lead a high-performing MSAT team, including scientists and engineers.
• Provide mentorship, technical guidance, and performance management.
• Develop MSAT strategy aligned with organizational growth and client pipeline.
• Perform other duties as assigned by the Head of Development.
Required Qualifications
• PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or a related field.
• 10–15+ years of experience in biopharmaceutical manufacturing or process development.
• 5+ years of leadership experience in MSAT, technical operations, or process development.
• Strong experience in cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).
• Experience working within a CDMO environment strongly preferred.
• Deep knowledge of:
• Cell culture and expansion technologies
• Viral vector transduction or gene editing workflows
• Closed and automated cell therapy manufacturing platforms
• Cryopreservation and fill-finish processes
• Experience with technology transfer, process validation, and process characterization.
• Familiarity with statistical process monitoring and data analytics tools.
• Strong cross-functional leadership and project management skills.
• Experience working directly with biotech clients.
• Excellent written and verbal communication skills.
• Ability to operate in a fast-paced CDMO environment supporting multiple client programs.
Preferred Qualifications
• Experience with commercial cell therapy manufacturing.
• Experience with automated manufacturing platforms (e.g., CliniMACS Prodigy, Lonza Cocoon).
• Knowledge of viral vector manufacturing processes.
• Experience supporting BLA submissions or late-stage clinical programs.
Physical Requirements
• Ability to perform essential job functions in compliance with ADA, FMLA, and other applicable regulations, including meeting productivity standards.
• Ability to maintain regular and punctual attendance.
• Must be willing to become gown-qualified and work in BSL-2 lab, CNC, ISO7, and ISO8 environments.
• Ability to lift and carry up to 30 lbs.
• Ability to bend, stoop, reach, climb, and stand on elevated surfaces as needed.
• Ability to sit or stand for extended periods.
• Must be comfortable working with cell-based products, chemicals, or hazardous materials.
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
- $97,000.00 Salary Description ABOUT THE ORGANIZATION The Foundation for the National Institutes of Health (FNIH) connects the world's leading public and private organizations to accelerate biomedical breakthroughs for patients, regardless of who they are, where they live, or what disease they have.
Together with leading scientists and problem-solvers, and a successful track record of navigating complex problems, the FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and train the next generation of scientists.
Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501 (3) charitable organization.
For more information about the FNIH, please visit .
EOE STATEMENT We are an equal employment opportunity employer.
Applicants must be currently authorized to work in the United States for any employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
DESCRIPTION The Foundation for the National Institutes of Health (FNIH) is seeking an Associate Project Manager (APM) to support major, multi-stakeholder research partnerships with diverse stakeholders, including biopharmaceutical companies, nonprofit healthcare organizations, government agencies, and academic scientists.
The APM will work closely with scientific and technical leads to support the day-to-day management and coordination of high-impact translational science research initiatives.
This is an early-career role for individuals with a strong scientific or research background who are interested in building a career in project and program management within public-private partnerships.
Positions at FNIH offer unique exposure across disciplines, sectors, and stakeholders, as the organization operates at the intersection of government, academia, industry, and nonprofit research.
Work will be conducted under the supervision of multiple senior Project Managers in a hybrid work environment, with time spent both virtually and at the FNIH offices located in North Bethesda, Maryland.
This role is a non-research, associate project management position that supports the planning, coordination, and execution of complex biomedical initiatives.
It requires strong interpersonal and written communication skills, excellent organizational abilities, high attention to detail, sound judgment, and diplomacy, along with the ability to work effectively under tight deadlines in a highly collaborative environment.
Familiarity with biomedical research settings is essential.
Reporting to the Program Manager, the APM will work under the supervision of senior Project Managers.
Responsibilities include, but are not limited to: Support large-scale, multi-stakeholder neuroscience research initiatives, including Accelerating Medicines Partnership (AMP) programs (e.g., Alzheimer's Disease, Parkinson's Disease, Amyotrophic Lateral Sclerosis (ALS), and Schizophrenia).
Work closely with Project Managers and Senior Project Managers to support day-to-day project coordination, governance activities, and operational execution.
Prepare, format, and quality-check meeting materials, including agendas, slide decks, meeting minutes, summaries, and follow-up documentation.
Schedule meetings and coordinate meeting logistics using Microsoft Teams and Outlook calendars; track action items, decisions, and deliverables across multiple workstreams.
Maintain a well-organized project documentation, trackers, and centralized repositories to support governance, reporting, and compliance requirements.
Assist with scientific and operational project activities, including tracking research milestones, deliverables, and timelines.
Support coordination among industry, academic, nonprofit, and government partners in a matrixed environment without direct reporting authority.
Assist with vendor coordination, budget tracking, invoicing, and contract-related documentation.
Draft and edit high-quality written materials, including meeting notes, scientific progress reports, manuscripts, presentations, newsletters, website updates, and external communications.
Develop clear, professional PowerPoint presentations that synthesize complex scientific and operational information for leadership and external stakeholders.
Gradually assume increased ownership of defined workstreams, with the expectation of independently leading small meetings within approximately one year.
This is a developmental role designed to prepare individuals for advancement into higher-level project management roles at FNIH.
FULL-TIME/PART-TIME Full-Time LOCATION FNIH Offices (North Bethesda, Maryland) POSITION REQUIREMENTS Successful candidates for the Associate Project Manager, Translational Science role will be able to demonstrate : Core Skills Strong organizational, time management, and written and verbal communication skills Proven ability to manage multiple priorities in a fast-paced, collaborative, matrixed environment High attention to detail Proficiency with Microsoft Office tools, particularly PowerPoint, Word, Excel, Teams, and Outlook.
Proactive, team-oriented mindset with a clear interest in long-term career growth in scientific project management.
Education & Experiences Master's or PhD degree in Neuroscience or a related scientific discipline preferred but not required; a strong scientific, biomedical, or public health research background is highly valued.
Early-career PhD candidates (1-3 years post-degree or equivalent experience): Demonstrated interest in transitioning from hands-on research into project or program management, supported by experience coordinating complex research efforts, collaborations, or multi-lab initiatives (e.g., consortium work, cross-lab projects).
Early-career MS candidates (1-3 years of experience): Demonstrated organizational, coordination, or project support experience within research, clinical, or scientific program environments.
A minimum of 1 year of professional experience, ideally within healthcare, government, scientific research, biotechnology/pharmaceutical, or nonprofit sectors is required.
1 year of experience working with scientific stakeholders, collaborators, or clients (preferred).
Exposure to the culture, systems, and organizational structures of NIH, FDA and/or the pharmaceutical industry is a plus.
Some experience supporting or working with contracts, agreements, or administrative documentation (preferred).
Prior experience in a consulting, client-facing, or nonprofit research setting (preferred).
Compensation details: 0 PIae2b9f917e1e-3725
Duration: 17+ Months
Location: Foster Coty, CA94404
Client's Process Technologies & Development team is seeking a highly motivated contractor to play a foundational role in establishing and operationalizing a new Primary Container Development Laboratory. This role is ideal for a hands-on individual who enjoys building systems from the ground up and maintaining high standards of scientific rigor.
The contractor will support the setup of the new lab facility, ensure equipment is properly installed, qualified, and maintained, and develop organizational systems to keep laboratory operations running smoothly. The role also involves operating a wide range of laboratory equipment, designing and executing high-quality experiments, supporting method readiness, and maintaining scientific excellence.
This position directly supports development workflows involving container closure systems, device interface evaluations, product compatibility studies, and process characterization.
Key Responsibilities
Laboratory Operations & Equipment Expertise
- 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:
- 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.
Scientific Excellence & Continuous Improvement
- 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.
Minimum Qualifications
- 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.
Preferred Qualifications
- 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:
- 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.
Why Join Us?
This contract role offers the opportunity to support high-impact development programs, expand technical expertise in primary container development, and collaborate with cross-functional teams working on advanced drug product development. The role directly contributes to ensuring the delivery of safe, stable, and high-quality medicines to patients.
Location: Worcester, MA; 01604
Duration: 8+ months
Description:
Overview:
A scientist position is available within the Cell Culture Process Development group in PDS&T Biologics at Client's Bioresearch Center in Worcester, MA. The group is responsible for developing and supporting cell culture manufacturing processes for early and late phase clinical programs. We strive for speedy delivery of quality processes that are high yield, amenable to efficient manufacturing operations, robust and provide desirable product quality attributes. The group interacts closely with other development groups and along with Manufacturing and Discovery. We are seeking an enthusiastic, creative scientist that can work independently and as part of a dynamic team environment.
What are the top 3-5 skills, experience or education required for this position:
- 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.
