Lead Formulation Development Specialist

2 days ago

Cochin, Kerala, India beBeePharmaceutical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Title: Pharmaceutical Process Development Manager

Job Description:

  • The ideal candidate will have 12-16 years of experience in formulation development, with a strong background in pharmaceutical processes and technologies.

Responsibilities:

Key Responsibilities
  • Process Optimization: Design and optimize manufacturing processes with technical improvements for regulated markets within allotted timelines.
  • Evaluation and Risk Assessment: Evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
  • Site Selection: Screen manufacturing sites based on formulation and process complexity/feasibility.
  • Technology Transfer: Lead technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches with stipulated time.
  • Product Transfer: Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  • SME Role: Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  • Standards Implementation: Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with CFTs.
  • Capacity Enhancement: Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • Compliance Review: 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.

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