Sr Scientist, Analytical Development

Recruiter
Apex Life Sciences
Location
San Francisco, California
Posted
Oct 31, 2019
Closes
Nov 21, 2019
Ref
b061accf27f4
Organization Type
Corporate
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

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