Senior Pharmaceutical Development Formulation Manager

1 day ago

Mumbai, Maharashtra, India beBeePharmaceutical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Formulation Manager Position Overview">

The ideal candidate will possess expertise in formulation development, process optimization, and technical improvements for regulated markets. This role requires strong knowledge of dosage forms and process optimization.

Key Responsibilities:
  • Design and optimize manufacturing processes for regulated markets (US, Canada, EU) within allotted timelines.
  • Evaluate manufacturing processes using Design of Experiments (DoE) and Quality by Design (QbD) to define design space, control strategy, critical/key parameters, and identify process risks.
  • Screen manufacturing sites based on formulation and process complexity/feasibility.
  • Lead Technology transfer functions with adequate project management skills to ensure successful scale-up of new products and effective launches.
  • Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  • Serve as Subject Matter Expert (SME) for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  • Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with Cross-Functional Teams (CFTs).
  • Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • Review and approve departmental Standard Operating Procedures (SOPs) to ensure compliance with current Good Manufacturing Practices (cGMP) and Quality Assurance (CQA) guidelines, technical changes, change control, deviations, and relevant documents.
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