Manager Formulation Development and Research

6 days ago

Palakkad, Kerala, India Unichem Laboratories Limited Full time

Experience - 12 to 16 Years

Qualification - M Pharm

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. .

Desired Skills

  • 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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