Scientist I - Biologics CMC Development
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- Medical Benefits
- Paid Sick leave
- 401K
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
