Senior Scientist or Director, CMC - Drug Substance and Drug Product

Stealth Peptides

Manufacturing

May 12, 2014

Senior Scientist or Director, CMC - Drug Substance and Drug Product 

JOB SUMMARY: We require a highly motivated scientist to lead outsourced peptide drug substance process development and drug product formulation development programs.  The ideal candidate will have demonstrated success leading both internal and outsourced CDMO resources to set project strategy and execute to a timeline.  The candidate shall perform both strategy-level and work plan tasks, as the programs demand.  Experience writing CMC sections of an NDA or CTD is also desired.

DUTIES AND RESPONSIBILITIES:

  • Write and communicate top level project plans, formulation development plans, and process development plans.
  • Review master batch records, executed batch records, chemical synthesis and process development protocols and reports. 
  • Lead CDMO interactions and manage work to plan.

REQUIRED BACKGROUND AND EXPERIENCE:

  • PhD Degree in Pharmacy, Biochemistry, Chemical Engineering, Chemistry, or related disciplines. 
  • Eight plus years of industry experience
  • Familiarity with excipient and presentation options in parenteral and oral dose forms.
  • A working understanding of drug substance physiochemical properties in drug product processing and product performance.
  • Knowledge of analytical methods, including mass spectroscopy, structure analysis, HPLC, and the method validation process.
  • Established track record of significant contributions as an individual technical expert and as a leader of innovator-CDMO partnered project teams.
  • Excellent written and oral communication skills.

ADDITIONAL DESIRABLE BACKGROUND:

  • Working knowledge of organic chemistry and chemical synthesis.
  • Experience identifying and resolving the mechanism/s of peptide instability.
  • Experience writing IOQ PQ, process validation, and/or test method validation protocols/reports

Apply Now

  • Company Stealth Peptides
  • Contact Name HR Manager
  • Contact Phone 617-600-6888
  • Contact Fax 617-600-6884
  • Email careers@stealthpeptides.com
  • Website http://www.stealthpeptides.com
  • Position Location Newton, MA
  • Job Reference Code 6201
  • Minimum Required Education Ph.D.
  • Minimum Preferred Education Ph.D.
  • Minimum Years Experience 8
  • Career Level Manager
  • Size of Company in MA 20
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