Scientist - Biologics CMC Development
Listed on 2026-10-03
-
Research/Development
Pharmaceutical Science/ Research, Research Scientist, Biotech Research, Biotechnology -
Pharmaceutical
Pharmaceutical Science/ Research, Biotechnology
Foster City, CA, United States | Posted on 09/30/2026
Our client, a global leader in biotechnology, is seeking a highly motivated
Scientist Ito join its Formulation Drug Development team for Foster City, CA.
Duration:
Long term contract (Possibility of further extension)
Pay Rate: $62/hr on W2 + Medical Benefits, Paid Sick leave, 401K
This role will focus on advancing biologic medicines into clinical development through innovative formulation development, drug product (DP) process development, and clinical in-use evaluations. The ideal candidate will bring hands-on laboratory experience, technical expertise in biologics formulation and process development, and the ability to collaborate with cross-functional teams to drive scientific innovation and support clinical-stage development
Responsibilities:
- Design and execute formulation and drug product process development activities, including formulation development, drug product manufacturing process development, and clinical in- use evaluations.
- Drive scientific innovation, expand technical expertise, and contribute to publications, presentations, and external scientific collaborations.
- Apply knowledge of analytical techniques, biophysical characterization, and process development methods to support drug product development.
- Lead by example in laboratory execution and contribute to the development of new technical capabilities.
- Ensure data integrity and adherence to Good Documentation Practices (GDP) in data collection, analysis, and report generation.
- Critically review internal and external technical documentation for accuracy, completeness, and compliance.
- Author technical documents, including protocols, reports, and regulatory dossier materials for internal and external stakeholders.
- Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field with 0+ years of relevant experience; or
- M.S. degree with 6+ years of industrial experience in biologics CMC development; or
- B.S. degree with 8+ years of industrial experience in biologics CMC development.
- Hands-on laboratory experience in biologics formulation or drug product process
- development.
- Experience in biologics CMC development and technical documentation.
- Experience in formulation development, drug product process development, and clinical in- use evaluation for:
- Monoclonal antibodies (mAbs)
- Bispecific antibodies
- Other complex biologics formats
- Experience with analytical methods, biophysical characterization, or drug product process development techniques.
Biologics CMC Development, Process Development, Formulation Development, mAb
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