Senior Scientist, Analytical Development
- Employer
- Principia Biopharma
- Location
- South San Francisco, CA, United States
- Start date
- Oct 31, 2020
View more
- Discipline
- Information Technology, Science/R&D, Biotechnology
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Biotech Bay
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Essential Job Functions:
Qualifications:
Principia Biopharma is an equal opportunity employer.
- This position will manage analytical activities at CMOs and CTOs for Phase 1 to late stage drug development
- Oversee technology transfer and validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTOs
- Identify and characterize drug impurities and degradation products
- Perform analytical method development for drug substances, starting materials, intermediates and drug products
- Characterize and maintain reference materials
- Characterize physical and chemical properties of drug candidates
- Oversee and review in-process and release testing for drug substances and drug products at CMOs/CTOs
- Summarize batch analysis data and track impurities throughout the drug substance synthetic process
- Design and monitor stability studies and trend stability and release data using statistical methods
- Review analytical documents and development reports
- Collaborate with QA, CMC team and CMOs towards timely generation and approval of documents
- Write technical reports and documents in support of regulatory filing
- Prepare CMC documents for INDs/IMPDs and NDAs/MAAs
Qualifications:
- MS or Ph.D. in chemistry or pharmaceutical sciences
- 7+ years in analytical development
- Strong organizational abilities and communication skills
- Self-directed and motivated
- Collaborative and team work
- Experience with CTOs and CMOs
- Expert knowledge in regulatory, ICH and cGMP requirements
- Proven track record in applying analytical techniques to solve challenging problems
- Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LCMS, GC, KF, UV/Vis, IR, PSA, dissolution testing, DSC, and TGA.
Principia Biopharma is an equal opportunity employer.
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