Senior Scientist, Analytical Development

Location
South San Francisco, CA, United States
Posted
Jul 25, 2021
Ref
459843395
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Essential Job Functions:
  • 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.