Scientist I Biologics CMC Development
California, CA - USA
Job Summary
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
- 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
- Antibody-drug conjugates (ADCs)
- Fusion proteins
- Other complex biologics formats
- Experience with analytical methods biophysical characterization or drug product process development techniques.
Required Skills:
Biologics CMC Development Process Development Formulation Development mAb
Required Education:
Biologics CMC Development Process Development Formulation Development mAb