Senior Formulation Development and Process Optimization Specialist

7 hours ago


Mysore, Karnataka, India beBeeFormulation Full time ₹ 25,00,000 - ₹ 35,00,000
Senior Formulation Development and Process Optimization Specialist

We are seeking an experienced Senior Formulation Development and Process Optimization Specialist to join our team. The ideal candidate will have a strong background in formulation development, process optimization, and technology transfer.

The successful candidate will be responsible for designing and optimizing manufacturing processes with technical improvements for regulated markets (US, Canada, EU) within allotted timelines.

Key Responsibilities:

  • Design and optimize manufacturing processes using design of experiments (DoE) and quality by design (QbD)
  • Evaluate manufacturing processes 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

Requirements:

  • 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 USFDA, 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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