Manager Pharmaceutical Process Development

2 days ago

Gandhinagar, Gujarat, India beBeeFormulation Full time ₹ 17,52,000 - ₹ 2,14,52,000
Job Title: Manager Formulation Development and Research

We are seeking a seasoned professional to lead our formulation development efforts.

  • This role requires a strong background in formulation development, with at least 12 years of experience in the pharmaceutical industry.
  • The ideal candidate will hold a Master's degree in Pharmacy (M Pharm) and possess excellent communication, documentation, and analytical skills.
Key Responsibilities:
  • Design and optimize manufacturing processes for regulated markets in the US, Canada, and EU within tight 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 function with 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.
  • 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 Practice (cGMP) and regulatory guidelines.

The desired skills for this role include:

  • Expertise in formulation development of various dosage forms with a strong knowledge of process optimization.
  • Hands-on experience in technology transfer and scale-up.
  • Strong understanding of regulatory guidelines such as US FDA, EMA, and WHO.
  • Ability to work in a fast-paced, dynamic environment.
  • Project management and cross-functional coordination.

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