Manager - Formulation And Development
23 hours ago
Role Overview:
A leadership position responsible for managing F&D projects from concept to technology transfer, overseeing a team of scientists, and ensuring successful product filing support.
Key Responsibilities:
- Leading and managing multiple formulation development projects for regulated markets (e.g., US, EU).
- Designing and implementing
Quality by Design (QbD)
approaches for new product development. - Supervising, mentoring, and guiding a team of F&D scientists and executives.
- Reviewing and approving critical R&D documentation, including formulation reports, protocols, and
regulatory filings
. - Acting as a key interface for Technology Transfer to the Production and Quality Assurance teams.
- Budgeting, planning, and ensuring projects meet defined timelines and quality metrics.
Essential Requirements:
- M.Pharm (Pharmaceutics/Industrial Pharmacy mandatory).
- 5-8 years of experience with a minimum of 2 years in a leadership/supervisory capacity.
- In-depth knowledge of global regulatory guidelines (ICH, USFDA, EMA)
and drug product filing requirements (e.g., ANDA). - Demonstrated experience in successful scale-up and technology transfer of multiple products.
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