Senior Pharmaceutical Formulation Expert

7 days ago

Vellore, Tamil Nadu, India beBeePharmaceutical Full time ₹ 17,00,000 - ₹ 2,02,50,000
Job Title

We are seeking a highly experienced Formulation Manager to lead our development and research initiatives. The successful candidate will have expertise in formulation development, process optimization, and technology transfer.

  • This position is responsible for designing and optimizing manufacturing processes 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.
  • The ideal candidate should be able to 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.

Required Skills and Qualifications:

  • 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.

Benefits:

  • This role offers an exciting opportunity to work in a dynamic and innovative environment.
  • The successful candidate will receive a competitive salary and benefits package.

Others:

  • This position requires a strong background in pharmaceutical science and technology.
  • Applicants must be able to work independently and collaboratively as part of a team.

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