Senior Scientist, Analytical Development

Location
South San Francisco, California
Posted
Jul 31, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

Principia Biopharma is a clinical stage biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and inflammation. As such, we are comprised of a team of exceptionally talented scientists and business leaders. We are seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic and collaborative leader wiling to contribute to overall CMC analytical strategy and in particular contribute to analytical development strategy in support of discovery and developmental programs at Principia. The ideal candidate will contribute in a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department’s leadership and the willingness to grow in their responsibilities.

ESSENTIAL JOB FUNCTIONS

  • Oversee technology transfer and validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs
  • Establish and justify specifications for drug substances, starting material, intermediate and drug products
  • Identify and characterize drug impurities and degradation products
  • Perform analytical method development
  • 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
  • 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 and NDAs

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 in late stage drug development
  • Experience with CROs 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 HPLC, LCMS, GC, KF, UV/Vis, IR, PSA, dissolution testing. DSC, TGA, DVS, XRPD, hardness, and friability also desired.

Principia Biopharma, Inc. is an equal opportunity employer.