Senior Formulation Development and Process Optimization Specialist

13 hours ago

Bikaner, Rajasthan, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Senior Process Optimization Specialist

As a seasoned professional with 12-16 years of experience, you will design and optimize manufacturing processes for regulated markets. Your expertise in formulation development, process optimization, and regulatory guidelines such as USFDA, EMA, and WHO is highly valued.

You will lead technology transfer functions, ensuring successful scale-up of new products within stipulated timeframes.

  • Design and optimize manufacturing processes for regulated markets (US, Canada, EU).
  • Evaluate manufacturing processes using DoE and QbD to define design space and control strategy.
  • Lead Technology transfer function with adequate project management skills.
  • Serve as SME for pharmaceutical processes and technologies.

Key Responsibilities:

  • Define procedures for seamless product transfers between development and manufacturing.
  • Implement standards for formulation technology transfer.
  • Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines.

Requirements:

  • Expertise in formulation development of various dosage forms.
  • Hands-on experience in technology transfer and scale-up.
  • Strong understanding of regulatory guidelines.
  • Excellent documentation, communication, and analytical skills.

Work Environment:

This role requires strong cross-functional coordination and project management skills to work in a fast-paced dynamic environment.

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