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Analytical Development Director – Medical Devices

4 months ago

Boston, United States EPM Scientific Full time

Director Analytical Development – Medical Devices

  • Location: San Franciso, CA
  • Working situation: Hybrid
  • Level: Director



Our client is a novel biologics company pursuing research into exciting combination products and therapies looking for a Director Analytical Development with a passion for curing and enhancing lives of patients. As the Analytical Development Director, you will be a key architect in ground breaking R&D research.


The ideal candidate for this role has experience supporting materials science/biomaterials and using analytical testing techniques common in solid-state chemistry/surface chemistry.


As the Director, Analytical Development – Medical Devices, you will:

  • Develop and execute a visionary analytical development strategy aligned with mission and goals, driving the firm closer to commercialization
  • Define and plan out strategies for mid-to-late-stage development in the drug product lifecycle
  • Harness your mastery in Analytical Tech Transfer, Validation, HPLC, Spectroscopy, Stress Testing, and other specialized analytical development techniques
  • Leverage your proficiency in supporting large molecules/biologics
  • Lead cross-functional project teams of 2-4 scientists and engineers to drive and execute CMC development plans
  • Partner with CMC and Quality, to support cGMP manufacturing


As the Director, Analytical Development – Medical Devices, the ideal qualifications are:

  • Bachelor’s Degree with 10+ years of experience, OR Master’s Degree with 8+ years of experience, OR Ph.D. with 6+ years of industry experience
  • Experience in contributing to CMC efforts from Phase I to Phase III (desired)
  • Experience with specialized analytical techniques like: DSC, spectroscopy, microscopy, stress/strain testing for medical devices or combination products


Company Benefits:

  • Competitive 401K program, health insurance, and HSA accounts
  • Long term incentives in terms of equity or stock at this level
  • Working at a Top 50 places to work on LinkedIn


If you are interested, please apply by clicking here.