Scientist - Biologics CMC Development
Listed on 2026-10-11
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Research/Development
Pharmaceutical Science/ Research, Research Scientist, Biotech Research, Biotechnology -
Pharmaceutical
Pharmaceutical Science/ Research, Biotechnology
Our client, a global leader in biotechnology, is seeking a highly motivated Scientist I to 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.
ResponsibilitiesDesign 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.
Required Qualifications- 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 Antibody-drug conjugates (ADCs) Fusion proteins Other complex biologics formats - Experience with analytical methods, biophysical characterization, or drug product process development techniques.
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