Formulation Development Manager

LOCK SEARCH GROUP

Formulation Development Manager

Montreal, QC

Description:

Our client, a leader in the pharmaceutical industry, is currently seeking a Formulation Development Manager to join their team on the South Shore of Montreal. The incumbent of the position will oversee a small team of research assistants and research scientists.

Main responsibilities:

  • Participate and oversee development and pilot plant scale-up of solid oral immediate, modified-release dosage forms, oral liquid, sterile injectable and ophthalmic projects
  • Write opinions about patents
  • Review the patent data compiled by the scientific research team and provide recommendations on the finalization of the development strategy and periodic updates
  • In collaboration with the Analytical Department, coordinate the Patent Cell, Pilot Plant, Warehouse, Technology Transfer, Project Managers and Regulatory Affairs to resolve issues
  • Study letters of deficiencies and non-compliance issued by regulatory bodies
  • Review and approve development reports and supporting documents for regulatory submission
  • Study and approve batch production records, use of quarantine excipients and active ingredients, different compositions, etc.
  • Provide technical input to licensed and co-development projects
  • Coordinate with suppliers to obtain samples of excipients, packaging materials, services, literature, etc.

Profile:

  • PhD, MSc or BSc
  • 10 years of experience, including at least 3 to 5 years in a supervisory position in a generic organization, mainly in solid forms
  • Extensive knowledge of development of solid oral dosage forms, liquids and/or sterile injectable and ophthalmic products and familiar with GMP principles, regulatory and patent related aspects
  • Have published articles in journals and have granted Patents to his credit
  • Have developed and gained experience in submission and approval of products to EU, US and Canadian regulatory authorities
  • French is an asset

If you are interested in this opportunity, please send your resume to Celine Chabee at cchabee@groupelock.com

Only qualified candidates will be contacted.

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