Job Description

Company:

Eidos Therapeutics

Role Title:

Director, Analytical Development

Summary:

Responsibility for all analytical development of early and late stage small molecule programs at Eidos Pharmaceuticals. Overseeing late development/launch development activities including (but not limited to): analytical method transfer, test method development and phase appropriate validation for both drug substance and drug product methods. Position requires close collaboration with both drug substance and formulation chemists as well as Quality (QA, QC). Analytical techniques include HPLC, GC, GC/MS, ICP, dissolution (discriminating and USP), UV, NMR, XRPD, Karl Fischer titration, DSC, TGA.

Responsibilities:

  • Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.)
  • Travel, when necessary, to 3rd party manufacturing and/or testing sites
  • Oversee 3rd party development of analytical methods, method validation, and investigations for out of specification, out of trend, and/or anomalous results
  • Knowledge of how and when to appropriately apply  cGMP requirements; ability to distinguish regulated and non-regulated activities
  • Collaboratively plan and execute cross functional studies for chemical development and formulation development.
  • Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to: HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation
  • Experience with disintegration, DSC, TGA, hardness, and friability testing is  desired
  • Qualification or validation of methods as appropriate for the stage of development.  Ideal candidate will be familiar with current statistical techniques used in method development and validation
  • NDA/MAA authoring experience is a plus
  • Able to communicate results both internally and externally through oral and written updates and formal reports as necessary

Requirements:

  • Ph. D./M.S. in life sciences, ideally Chemistry, Pharmacological Chemistry preferred. B.S. will be considered with additional 5 years industrial experience
  • 7+ years’ experience in analytical development in a pharmaceutical setting
  • Proven abilities in leadership and personnel management
  • Knowledge and direct experience with CMC analytical requirements for IND and NDA filing
  • Ability to communicate effectively with vendors regarding project scope, scientific results and project updates
  • Strong oral and written communication skills

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