Pharmaceutical Formulation Leader

1 day ago

Allahabad, Uttar Pradesh, India beBeeFormulation Full time ₹ 1,78,88,000 - ₹ 2,39,69,000
Job Title:

Senior Formulation Development Leader

About the Role:

We are seeking a highly skilled Senior Formulation Development Leader to join our team. The ideal candidate will have extensive experience in formulation development, process optimization, and technology transfer. They will be responsible for leading the formulation development function, ensuring the successful scale-up of new products, and implementing standards for formulation technology transfer.

Key Responsibilities:
  • 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.
  • Lead Technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches with stipulated time.
  • 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, with CFTs.
  • Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations, and relevant documents.
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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