Css Scientific Address Jobs in Usa

About the Company

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management. The Director will work closely with Technical Operations, Quality, Manufacturing, and Development teams and will represent CMC Regulatory in interactions with health authorities.

About the Role

This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management.

Responsibilities

• Lead the global CMC regulatory strategy for development and marketed products, ensuring alignment with business objectives and regulatory expectations.
• Provide oversight and authorship for CMC sections of regulatory submissions, including INDs/CTAs, BLAs/NDAs, supplements, variations, and annual reports.
• Act as the primary CMC regulatory representative in health authority interactions, including FDA meetings, scientific advice, and regulatory correspondence.
• Support CMC lifecycle management, including comparability assessments, post-approval changes, and regulatory impact evaluations.
• Partner cross-functionally with Technical Operations, Manufacturing, Quality, Analytical Development, and Supply Chain to ensure regulatory compliance and readiness.
• Ensure compliance with ICH guidelines, FDA, EMA, and other global regulatory requirements applicable to CMC activities.
• Contribute to internal governance forums, risk assessments, and regulatory decision-making processes.
• Build and maintain effective relationships with external partners, including CDMOs and regulatory consultants.
• Mentor and develop regulatory staff as appropriate, supporting a culture of regulatory excellence and accountability.

Qualifications

• 10+ years of Regulatory Affairs experience, with significant focus on CMC in pharmaceutical or biotechnology environments.
• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred.
• Demonstrated experience supporting IND, BLA, or NDA submissions, including CMC sections.
• Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).
• Experience collaborating with manufacturing, quality, and technical operations organizations.
• Proven ability to operate effectively in an SME environment, balancing strategic oversight with hands-on execution.
• Excellent written and verbal communication skills, with the ability to clearly convey regulatory requirements and risk.

Required Skills

Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).

Preferred Skills

Experience collaborating with manufacturing, quality, and technical operations organizations.

Pay range and compensation package

Competitive compensation and comprehensive benefits.

Equal Opportunity Statement

We are committed to diversity and inclusivity.

Executive Director, Clinical Development (MD)

On-site in San Diego

Must have an MD

Overview

The organization is seeking a senior physician leader with extensive experience in obesity and cardiometabolic drug development to establish and lead clinical strategy across its therapeutic pipeline. This role will provide medical and strategic direction for programs spanning early clinical research through late-stage development, with particular focus on obesity and related metabolic disorders.

The Executive Director will guide the advancement of novel therapeutics by integrating clinical science, regulatory strategy, and operational execution. The successful candidate will have a proven record of leading complex clinical programs, influencing cross-functional teams, and delivering high-quality clinical data in a biotechnology or pharmaceutical environment.

Key Responsibilities

Clinical Strategy & Portfolio Leadership

• Define and oversee clinical development strategy for obesity and metabolic disease programs across all phases of development.
• Provide senior medical leadership for study design, conduct, and interpretation, including endpoints, patient populations, safety oversight, and benefit–risk evaluation.
• Serve as the company’s internal medical authority for metabolic disease programs and advise executive leadership, project teams, and external partners.
• Contribute to portfolio prioritization, development sequencing, and long-term clinical planning aligned with corporate objectives.

Clinical Program Oversight

• Provide accountability for execution and quality of assigned clinical programs.
• Oversee development of clinical protocols, amendments, and integrated development plans.
• Ensure study deliverables are completed within timelines, budget, and quality expectations.
• Direct medical governance activities and ensure appropriate patient safety oversight across trials.

Regulatory & Safety

• Serve as the senior medical representative in interactions with regulatory agencies for assigned programs.
• Partner with Regulatory Affairs, Clinical Operations, Biostatistics, CMC, and Program Management to align development and submission strategies.
• Lead medical contributions to key regulatory documents including INDs, investigator brochures, clinical study reports, and regulatory briefing materials.
• Participate in regulatory meetings and health authority interactions (e.g., FDA, EMA).
• Maintain compliance with GCP, ICH guidelines, and applicable regulations.

Cross-Functional Leadership

• Lead collaboration across clinical operations, pharmacovigilance, translational sciences, biostatistics, and commercial teams.
• Provide mentorship and leadership to clinical staff and contribute to building organizational capabilities in clinical development.

External Engagement

• Build relationships with key opinion leaders, investigators, and advisors in obesity and metabolic disease.
• Represent the organization at scientific conferences, advisory boards, and investigator meetings.

Qualifications

• Medical degree (MD) required
• 10+ years of clinical development experience within the pharmaceutical or biotechnology industry
• Demonstrated experience leading clinical studies in obesity or metabolic disease
• Significant leadership experience, including oversight of teams or programs
• Track record of directing clinical programs across multiple development stages
• Strong understanding of drug development strategy, clinical operations, and planning
• Expertise in clinical data analysis and interpretation
• Familiarity with SOPs, GCP, ICH guidelines, and regulatory compliance
• Ability to travel approximately 25%

Preferred

• Experience supporting regulatory submissions and agency interactions (IND, NDA/BLA)
• Board certification in Endocrinology, Diabetes, Metabolism, or related specialty
• Experience within a clinical research or biotech operational environment
• Excellent written and verbal communication skills, including presentation of complex data to varied audiences

Core Competencies

• Strategic thinking and program prioritization
• Strong cross-functional collaboration and leadership
• Effective decision-making and problem solving
• Organizational and communication skills
• Ability to manage shifting priorities in a dynamic environment

Compensation & Benefits

• Full-time position
• Competitive compensation based on experience
• Equity participation and performance bonus eligibility
• Retirement plan with employer match
• Medical, dental, and vision coverage
• Flexible spending programs
• Life insurance and employee assistance programs
• Paid time off and holidays

Bioinformatics Scientist – Antibody Discovery

A growing global veterinary pharmaceuticals organisation is looking for a Bioinformatics Scientist to support antibody discovery programmes for companion animals (dogs, cats, horses).

Working closely with senior R&D leadership, this role will focus on applying bioinformatics, sequencing data analysis and protein modelling to identify and optimize therapeutic antibody targets.

Key Responsibilities

• Analyse genomic, DNA-seq and RNA-seq datasets to support antibody discovery
• Apply bioinformatics and modelling approaches to evaluate and optimize antibody candidates
• Contribute to protein modelling and in-silico antibody engineering (e.g. liability remediation, biophysical optimization)
• Curate and integrate genomic datasets for companion animal species
• Collaborate closely with discovery biology and R&D teams

Key Requirements

• At least 1 year of experience working with therapeutic antibodies (essential)
• Experience analyzing next generation sequencing datasets (DNA / RNA-seq)
• Background in bioinformatics, computational biology or structural biology
• Familiarity with protein modelling / antibody engineering tools (e.g. MOLE, Rosetta or similar)
• Strong communication skills and ability to work cross-functionally with scientific teams

This is an exciting opportunity to contribute to cutting-edge biologics discovery in animal health, helping develop next-generation therapies for companion animals.

If interested, please reach out for a confidential discussion.

Research Scientist – Pulp & Paper Enzymes

Location: Raleigh, NC

Type: Full-time | On-site

We are seeking a Research Scientist to help lead experimental and applied research supporting enzyme applications in the pulp and paper industry. This role will focus on designing and executing lab experiments, supporting customer projects, and helping advance new enzyme-based solutions for mill operations.

Key Responsibilities

• Design and execute laboratory experiments to support technical projects and customer needs

• Provide benchtop proof-of-concept work and technical support for field applications

• Oversee project timelines and guide Research Associates to ensure accurate completion of experiments

• Write technical reports summarizing results for both technical and non-technical audiences

• Develop and refine experimental methods and laboratory procedures

• Train team members on laboratory techniques and safety protocols

• Maintain laboratory equipment, calibration schedules, and SOP documentation

• Document experimental results in electronic laboratory notebooks (ELN)

• Manage laboratory inventory and supplies

• Collaborate with industry partners, mill R&D teams, and research organizations

Qualifications

• PhD or MS in a relevant field (Pulp & Paper Engineering, Chemical Engineering, Chemistry, Microbiology, Biology, etc.)

• Proven ability to manage and execute scientific research projects

• At least 1+ year of laboratory experience (lab management experience preferred)

• Strong analytical, problem-solving, and independent working skills

• Experience in the pulp & paper industry or enzyme applications is a plus

• Mechanical aptitude or experience troubleshooting laboratory equipment is a plus

• Ability to lift up to 55 lbs and perform physical lab tasks

• Willingness to travel occasionally to mill sites (

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• Perform cell line expansion, maintenance, cryopreservation, and thawing of multiple mammalian cell lines.
  
• Prepare cell culture media with complex supplements and ensure proper cell handling procedures.
  
• Collaborate with team members to support cell culture needs for ongoing research projects.
  
• Coordinate with cross-functional teams to assess cell banking and cell culture requirements and deliver materials within timelines.
  
• Conduct and support cell line quality control procedures, including validation for experimental integrity.
  
• Maintain accurate laboratory notebooks and documentation for all experiments and lab activities.
  
• Support development of genetically engineered cell lines and in-vitro cell-based assays for oncology programs
  

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• Bachelor's degree in Molecular Biology, Cell Biology, Cancer Biology, or related life science field.
  
• Minimum 3 years of hands-on experience working with:
  
  • 
    
  • Cancer cell lines
    
  • Primary cells
    
  • Genetically engineered cell lines
    
  
  
  
• Strong expertise in aseptic techniques and mammalian cell culture.
  
• Experience handling multiple cell lines simultaneously.
  
• Proficiency in media preparation with complex supplements.
  
• Strong organizational skills, attention to detail, and record-keeping abilities.
  
• Familiarity with cell culture QC practices, including:
  
  • 
    
  • Mycoplasma testing
    
  • Cell line authentication.
    
  
  
  

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• 6+ years of hands-on experience in mammalian cell culture within the biopharmaceutical or biotechnology industry.
  
• Experience using electronic lab notebooks (ELN) for experiment documentation and workflow management.
  
• Ability to optimize and troubleshoot mammalian cell culture systems.
  
• Experience writing and maintaining Standard Operating Procedures (SOPs).
  
• Familiarity with online genetic databases and integration of phenotypic/genetic data into cell bank systems.
  
• Experience with viral and non-viral transduction or transfection methods, including:
  
  • 
    
  • Lentivirus
    
  • Retrovirus
    
  • Lipid-based systems
    
  
  
  
• Experience using laboratory instruments such as:
  
  • 
    
  • Plate readers
    
  • Cell counters
    
  • Automated western blot systems
    
  
  
  
• Ability to run basic cell-based assays and develop cell line banking protocols.
  
• Strong written and verbal communication skills.
  
• Ability to work effectively in a fast-paced environment with shifting priorities.
  

Open date: June 14, 2025

Most recent review date: Tuesday, Jul 29, 2025 at 11:59pm (Pacific Time)

Applications received after this date will be reviewed by the search committee if the position has not yet been filled.

Final date: Tuesday, Aug 25, 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 College of Chemistry at the University of California, Berkeley is generating an applicant pool of qualified lecturers to teach graduate courses on the Berkeley campus for the Master of Molecular Science and Software Engineering (MSSE) Program should an opening arise. We are seeking dynamic lecturers with a commitment to graduate education in computational science, data science, and software engineering to lead multiple courses each year. Disciplines where we are seeking instructors include:

• 
  
• Computational Chemistry
  
• Computational Quantum Chemistry
  
• Scientific Computing
  
• Machine Learning/Deep Learning
  
• Structural Bioinformatics
  
• High Performance Computing
  
• Complex mathematical modeling and simulations
  
• Leadership, management, and entrepreneurship
  

The MSSE Program is a unique program that is designed to formally train scientists, engineers, and computer scientists in computational and data science, and to provide them with the tools, software engineering practices, leadership, management, and entrepreneurial skills needed to create or lead science- or engineering-based enterprises. While the degree focuses on the molecular sciences, its content is suitable for any student pursuing software engineering or data science roles in other science-based industries, or in other areas that require advanced machine learning, complex mathematical modeling and simulations, or high-performance computing.

General Duties:

Classroom teaching and preparation, managing and mentoring graders and/or graduate student instructors (teaching assistants), holding office hours, assigning grades, advising students, preparing course materials (e.g., syllabus), and using Cal's electronic resources for course management.

The MSSE Program seeks candidates who can support the success of all students through inclusive curriculum, classroom environment, and pedagogy.

Program:

Contract for the Lecturers Unit (IX) between the University of California and the American Federation of Teachers:

Advanced degree or enrolled in an advanced degree program.

Advanced degree.

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• A Ph.D., or equivalent international degree, in an area related to computational science, data science, and/or software engineering
  
• Prior teaching and/or work experience in computational science, data science, and/or software engineering
  
• Leadership, management, and entrepreneurial skills in STEM fields
  
• Existing authorization to work in the U.S.
  
• Proficient in C++ and Python programming languages
  

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

  
  

• Cover Letter (Optional)

  
  

• Statement of Teaching

  
  

• 3-5 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.

• 
  
• "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
  

Description

Ready for more than just a job? Build a career with purpose.

At Lactalis in the USA, we're committed to providing meaningful opportunities for our people to learn, grow, and thrive-whether you're just starting your journey with us or looking to take the next step in your career. From day one, we offer the tools and support to help you succeed.

As the world leader in dairy, Lactalis is a family-owned company with over 85,000 pragmatic and ambitious professionals across the globe. Each day, we're proud to produce award-winning dairy products that bring people together.

In the US, we proudly offer an unrivaled house of beloved brands, including Galbani Italian cheeses and ricotta, President specialty cheeses and butters, Kraft natural and grated cheeses, Breakstone's cottage cheese, Cracker Barrel, Black Diamond cheddar, and Parmalat milk. Our yogurt portfolio includes siggi's, Stonyfield Organic, Brown Cow, Oui, Yoplait, Go-Gurt, :ratio, Green Mountain Creamery, and Mountain High, along with a growing family of ethnic favorites like Karoun, Gopi, and Arz.

At Lactalis, we live by our core values-Ambition, Engagement, and Simplicity. We foster a workplace where innovation thrives, diverse perspectives are celebrated, and everyone's unique background and ideas are valued.

Even if you don't meet every qualification, we encourage you to apply. We want to hear about your PASSION, your STORY, and how your EXPERTISE can help us shape the future of dairy.

From your PASSION to ours

Lactalis USA, part of the Lactalis family of companies, is currently hiring a Sensory Science Intern based in Buffalo, NY. Join our R&D team as a Sensory Science Intern, where you will play a hands-on role in evaluating the taste, texture, and consumer appeal of our products. This is a comprehensive 12-month, on-site opportunity located in Buffalo, NY, designed for an individual eager to bridge the gap between food science and data-driven insights.

From your EXPERTISE to ours

Key responsibilities for this position include:

• Assist the sensory scientists in designing, planning, and executing R&D sensory evaluations (discrimination, descriptive, hedonic/consumer tests).
• Coordinate panel scheduling, sample prep, and sensory session setup. * Recruit, train, and calibrate sensory panelists for descriptive analysis.
• Analyze sensory data using appropriate statistical methods (T-Test, ANOVA, PCA, cluster analysis, preference mapping).
• Present sensory results to stakeholders in R&D, Marketing, Quality, and Manufacturing.
• Drive to various stores to obtain commercially available dairy products for use by sensory expert panels and other tastings as needed.

Requirements

From your STORY to ours

Qualified applicants will contribute the following:

Education

• Candidate will possess or be pursuing a Bachelors or Masters degree in scientific field (Biology, Chemistry, Agriculture, etc.; Dairy or Food Science a plus)

Experience

• Interest in Sensory Science is a plus. The description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities, tasks, and duties.
• Experience in conducting sensory testing, setup, and interpretation of results is a plus.

Competencies

• Strong attention to detail and excellent verbal and written communication skills.
• Need to be able to work independently and in teams, with minimal direct supervision.
• Demonstrated ability to interface and maintain effective relationships with all departments and employees in a team oriented organization.
• Ability to prioritize and meet deadlines within specified time constraints.
• Ability to operate in a transversal environment, across multiple departments.
• Ability to adapt in a changing work environment.
• Valid driver's license required.
• Ability to occasionally lift and/or move up to 50 pounds.

** This internship is expected to start at the end of March 2026 and end March 2027**

Lactalis is an equal employment opportunity employer. We will not discriminate against applicants with regard to any legally-recognized basis including, but not limited to: veteran status, race, color, religion, sex, national origin, age, marital status, sexual orientation, and physical or mental disabilities. Further, any division of the Company that is an Affirmative Action Employer will comply with all related legal obligations.

Description

Looking for a job that can grow into a lifelong career?
At Lactalis USA, we believe in promoting from within and giving our employees meaningful opportunities to learn, grow, and thrive. Whether you're just starting out or bringing years of experience, we'll provide the tools and support you need to succeed.

Lactalis is the world leader in dairy-a family-owned company with over 85,000 pragmatic and ambitious professionals across the globe. Every day, we're proud to produce award-winning dairy products that bring people together every day.

In the US, we offer an unrivaled house of beloved brands, including Galbani Italian cheeses and ricotta, President specialty cheeses and butters, Kraft natural and grated cheeses, Breakstone's cottage cheese, Cracker Barrel, Black Diamond cheddar, and Parmalat milk. Our yogurt portfolio includes siggi's, Stonyfield Organic, Brown Cow, Oui, Yoplait, Go-Gurt, :ratio, Green Mountain Creamery, and Mountain High, along with sour cream and a growing family of ethnic favorites like Karoun, Gopi, and Arz.

At Lactalis, we live by our core values-Ambition, Engagement, and Simplicity. We're building a workplace where innovation thrives, diverse perspectives are celebrated, and everyone's unique background and ideas are valued.

Even if you don't meet every qualification, we encourage you to apply. We want to hear about your PASSION, your STORY, and how your EXPERTISE can help us make an impact.

From your PASSION to ours

Lactalis US Yogurt, part of the Lactalis family of companies, is currently hiring a Quality Assurance Lab Technician based in Casa Grande, Arizona.

The Quality Assurance Lab Technician performs timely and accurate evaluations and analysis of raw materials, products, processes, and facilities that support the efficient manufacturing and shipment of quality products according to the specifications at our manufacturing facility.

The Quality Assurance Lab Technician starts at $21.00 / hour, plus shift differentials. This is a full-time opportunity available on 1st Shift (06:00 AM to 02:30 PM)

• 401K match up to 7% annually.
• Referral bonus programs ($750-1500)
• Comprehensive medical, dental, and vision
• FSA & HSA programs
• Education Assistance Program
• Paid time off includes 7 core holidays, 2 floating holidays, 2 volunteer days, and prorated vacation time up to 15 days
• Premium pay (overtime) when working on Sundays and core holidays
• And much more

From your EXPERTISE to ours

Key responsibilities for this position include:

• Responsible for all aspects of food safety and quality as defined by plant and department procedures.
• Collect, analyze, and evaluate samples from each step of yogurt production and approve for use in production or distribution using various test equipment, test procedures, and methodology.
• Hold product based on specifications and product knowledge.
• Monitor and approve production equipment sanitation, start-up, and performance using control devices and tests.
• Monitor the environment of the plant using various test equipment and procedures and communicate results to operations team on a regular basis, to include, but not limited to air sampling, swabbing equipment and drains.
• Perform audits on Good Manufacturing Practices in all areas of the plant.
• Prepare paperwork for use in reporting results to internal auditing, SQF auditing, and State Agencies.
• Maintain and calibrate test equipment using control devices and tests.
• Communicates with operations employees regarding issues, results, and status of evaluations daily.
• Utilize the Scientific Investigation Method through the course of daily work.
• Maintain a sanitary and well-stocked area.
• Perform other duties as assigned.

From your STORY to ours

Qualified applicants will contribute the following:

Education & Experience

• High School diploma, GED, and 3 to 6 months of related training and/or experience in a food manufacturing laboratory/quality assurance team.
• Experience working in a \"clean\" environment, utilizing aseptic methodologies, and performing bacteriological culture and laboratory analysis.

Skills / Abilities / Knowledge

• Ability to perform mathematical calculations and analysis.
• Ability to understand and follow company policies, standards, and specifications.
• Ability to understand, operate, and interpret results derived through typical laboratory testing procedures.
• Communicate effectively and accurately, both verbally and in writing.
• Take directions and follow instructions accurately.
• Work well with peers and supervisors across various teams.
• Proficient in Word, Excel, and SAP.
• Must be able to routinely lift up to 25 lbs.
• Must be able to work in a variable temperature environment.
• Must be able to stand and walk for extended periods of time.
• Must be able to stoop and reach on a regular basis, along with climbing and balancing.
• Routine exposure to mechanical machinery.
• Must be comfortable working in a multi-task, deadline, and consumer-driven environment.
• Close vision is required.

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• Independently performs and verify a multitude of laboratory techniques for which they are trained on while adjusting to unforeseen technical or logistical obstacles to accomplish assignments.
  
• Understands multiple laboratory techniques and principles and can independently trouble-shoot and resolve analytical techniques and instrument issues.
  
• Takes initiative to be a key player in team activities and decision making including proactive identification, development, and implementation of improvement plans.
  
• Budgets their time independently and effectively to carry out assigned tasks and makes recommendations for improvement.
  
• Recognizes obstacles to completion of assigned testing and can independently resolve them. Consistently achieves commitments despite obstacles.
  
• Takes ownership of special projects as needed to support overall laboratory needs and requirements.
  
• Communicates proactively with supervisor and team members on frequent basis to ensure timely product release.
  
• Interfaces with regulatory agencies during audit activities as needed.
  

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• Bachelor's Degree in the sciences with 0-4 years of laboratory experience
  
• Associate degree with at least 3 years of laboratory experience
  
• Flexibility in shift and workdays highly desirable
  
• Ability to work with general supervision but effectively manages their own time to multi-task based upon their completed training matrix.
  
• Good interpersonal, documentation, and communication skills.
  
• Desired technical competencies (not all required): LC, LCMS, GC, GCMS, ICP, Empower, Karl Fischer, dissolution, IR, titrations, and common wet chemical testing