LOCK SEARCH GROUP
Formulation Development Manager
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.
- 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.
- 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 email@example.com
Only qualified candidates will be contacted.