Senior Formulation Development Manager

2 weeks ago

Aurangabad, Maharashtra, India beBeeFormulation Full time ₹ 1,80,00,000 - ₹ 2,50,00,000
Senior Formulation Development Manager

Job Summary:

Results-driven Senior Manager with 12-16 years of experience in formulation development, research, and technology transfer seeks a challenging role that leverages expertise to drive innovation and growth.

Key Responsibilities:

  • Develop and optimize manufacturing processes for regulated markets (US, Canada, 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 strong 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.
  • Develop and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities.
  • 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 guidelines.

Required Skills and Qualifications:

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

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