Senior Manager Formulation Development

6 days ago

Davangere, Karnataka, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Description

We are seeking an accomplished Manager to oversee the formulation development and research process.

This role will be responsible for designing and optimizing manufacturing processes, evaluating process risks, and leading technology transfer functions. The ideal candidate will possess expertise in formulation development, strong knowledge of process optimization, and a deep understanding of regulatory guidelines.

  • Design and optimize manufacturing processes with technical improvements for regulated markets (US, Canada, EU) within allotted timelines.
  • Evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
  • Screen manufacturing sites based on formulation and process complexity/feasibility.

Key Responsibilities:

  • Lead Technology transfer function 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 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.
  • Initiate, drive and facilitate capacity enhancement, cost reduction and time cycle reduction projects.
Requirements

To succeed in this role, you will need:

  • 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.
About Us

We offer a challenging and rewarding work environment that fosters growth and development. If you are a motivated professional looking for a new challenge, we encourage you to apply.

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