Senior Scientist, Formulation and DP Development
$155,000–$168,000 year
On-siteSouth San Francisco, California, United States
South San Francisco, California, United StatesOn-siteFull Time$155,000–$168,000 yearSenior LevelDoctorate Or Professional DegreeMedium
Full TimeSenior LevelDoctorate Or Professional DegreeMedium
Job Summary
Conduct formulation and drug product development for biologic and conjugated molecules, including designing and executing stability, compatibility, and in-use studies. Participate in technology transfer to contract manufacturing organizations and implement analytical methods for biophysical characterization and process development. Communicate experimental data verbally and in written reports for regulatory filings while collaborating with cross-functional teams on multiple projects. Report to the Executive Director of Formulation and DP Development.
Required Qualifications
- BS/MS (12+ years) or PhD (7+ years) of experience in scientific discipline (Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or related discipline)
- demonstrated scientific creativity and contributions
- Solid technical skills and experience in pre-formulation screening studies
- biophysical/ biochemical characterization of proteins
- analytical method development
- protein/ antibody/ADC product development
- Practical experience with design and execution of in-use stability studies for biologics
- compatibility with administration components
- Demonstrated ability to design experiments
- routinely generate new ideas and original research
- High level of scientific initiative and independence
- Highly autonomous requiring minimal supervision from manager
- Working knowledge of cGMP and relevant drug product development guidelines and regulations
- Flexibility to work on multiple projects between departments in a fast-paced environment
- Excellent oral and written communication skills
- being detailed oriented
Desired Qualifications
- Analytical instrumentation such as chromatographic (HPLC, UPLC, column chromatography), visible and subvisible particle analysis, capillary electrophoresis and/or biophysical techniques (UV-vis, MALS/DLS, DSC, CD, FTIR, AUC, Fluorescence spectroscopy) for protein characterization
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