Staff Scientist – Research
| Company | Vaxcyte |
|---|---|
| Location | San Carlos, CA, USA |
| Salary | $177000 – $206000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related field with 8+ years of industry experience; or M.S. with 13+ years; or B.S. with 16+ years.
- Extensive expertise in vaccine formulation, stability studies, and drug product process development.
- Hands-on experience with protein conjugation, purification, and analytical characterization (e.g., HPLC, SEC-MALS, DSC, DLS, CD, ELISA).
- Proven ability to manage tech transfers, CMO interactions, and regulatory documentation.
- Strong leadership skills with a demonstrated ability to manage and mentor junior scientists.
- Experience in a GMP/GLP environment and knowledge of regulatory requirements for biologics is highly desirable.
Responsibilities
- Lead the design, optimization, and scale-up of vaccine formulations.
- Conduct stability studies (accelerated, long-term, and forced degradation).
- Develop and implement container closure system evaluations for drug substance (DS) and drug product (DP) materials.
- Drive troubleshooting and process improvements, identifying scientific gaps and proposing solutions to formulation challenges.
- Manage preclinical and toxicology material development, including bedside mix approaches for early-phase clinical programs.
- Support conjugation chemistry efforts for protein-polysaccharide vaccines, optimizing conjugation strategies for enhanced immunogenicity.
- Assist in protein purification workflows, including chromatographic separations, ultrafiltration, and characterization.
- Collaborate with analytical teams to ensure proper quality control and characterization of conjugates and formulated products.
- Lead and support tech transfer activities to CMOs, including documentation, troubleshooting, and process scale-up.
- Serve as the scientific lead in interactions with manufacturing, clinical, regulatory, and quality teams.
- Author key documents for regulatory filings, including IND-enabling studies, process development reports, and batch records.
- Drive the implementation of electronic lab notebooks (Benchling) and other digital tools to streamline documentation and data accuracy.
- Mentor and develop junior scientists, fostering technical growth and professional development.
- Provide strategic guidance in resource allocation and project timelines for formulation and process development programs.
- Contribute to scientific publications, patents, and conference presentations to advance Vaxcyte’s vaccine platforms.
Preferred Qualifications
- Experience in a GMP/GLP environment and knowledge of regulatory requirements for biologics is highly desirable.