Sr Scientist, Analytical Development

Location
94108, San Francisco
Salary
$120-150K
Posted
Jun 03, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

 

The Senior Scientist, Analytical Development will be responsible for developing analytical techniques to support drug substance and drug product formulation development activities. 

Responsibilities:

  • Develop analytical techniques to support drug substance process and drug product formulation development activities
  • Manage analytical method development to support characterization of drug substance and drug products
  • Apply scientific principles in selecting appropriate techniques for development of sensitive and robust methods
  • Troubleshoot analytical methods, hardware and software issues arising at CROs/CMOs
  • Research new techniques and recommend alternative approaches and potential solutions to analytical issues
  • Write analytical test methods, protocols and reports as part of analytical transfers to CROs/CMOs for GMP testing
  • Contribute to authoring of CMC sections to support regulatory filings
  • Serve as an analytical subject matter expert within department and cross-functional areas

Qualifications:

  • Ph.D in analytical chemistry or related disciplines, with at least 5 years relevant experience in pharmaceutical industry

Skills, Knowledge & Abilities:

  • Extensive knowledge and hands-on experience on chromatographic and spectroscopic techniques (e.g. GC, HPLC, MS, UV/Vis)
  • Knowledge of techniques required for physicochemical characterization of drug substance (e.g., particle size, TGA, DVS, DSC etc.)
  • Experience with analytical method validations and transfers in regulated environments is required
  • Experience with development and validation of methods for bioassay to determine potency is a plus
  • Attention to detail and excellent analytical skills as applied to data review and investigations
  • Passion for learning, creating, relating, communicating, and leading cross functional teams
  • Excellent verbal and written communication skills
  • Experience in a start-up environment preferred
  • Must be pro-active team player, flexible, and open to change