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Online Laboratory Magazine
10/22/2020

Senior Expert API & Chemical Process Development (m/f/d)


  • PhD (or equivalent) in organic chemistry with relevant experience in a GMP environment, chemical manufacturing experience and experience with collaborations with external partners
  • Long term relevant experience in a pharmaceutical R&D environment with long term experience in R&D labs and / or batch process development
  • Solid working knowledge of chemical process development and manufacture
  • Strong project management skills
  • In this role you take over technical leadership for Active Pharmaceutical Ingredients (APIs) in BIAH portfolio and are responsible for API-related activities of R&D projects during development phases - this includes the full development of new APIs, sourcing of generic APIs, and transfer of proprietary APIs processes in coordination with internal and external partners
  • You assess the manufacturing aspects of promising novel APIs in BIAH's Pharma Discovery & Research portfolio
  • You lead the development of New Chemical Entities (NCEs) liaising between external partners and BI R&D, procurement and QA - this includes Evaluation and selection of contract research and / or manufacturing organizations in or outside the BI Group, Selection of a commercial API manufacturer, Oversight and coordination of technical transfer to selected chemical manufacturers, Contribute to the preparation of the API portions sections of CMC and other regulatory filings
  • With regards to analytical standards of APIs and / or impurities on request of Analytical Sciences (AS), Drug Metabolism and Pharmacokinetic (DMPK) or Operations, you manage the manufacture at third parties


» Job description


Employer:
Boehringer Ingelheim Vetmedica GmbH
Location:
55218 Ingelheim