Senior Scientist, Analytical Development

Location
South San Francisco, CA, United States
Posted
Oct 31, 2020
Ref
459843395
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
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.