Formulation Development Director

4 days ago

Bhavnagar, Gujarat, India beBeeFormulation Full time ₹ 20,00,000 - ₹ 25,00,000

Job Opportunity:

We are seeking an experienced professional to lead our formulation development and research team.

Key Responsibilities:

  • Process Design and Optimization: Develop and refine manufacturing processes with technical improvements for regulated markets (US, Canada, EU) within allotted timelines.
  • Manufacturing Process Evaluation: Evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
  • Site Selection: Assess 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 Transfers: Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  • SME Support: Provide guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  • Standards and Compliance: Establish standards for formulation technology transfer and serve as point contact for formulation technology transfer activities, with CFTs.
  • Cycle Time Reduction: Drive capacity enhancement, cost reduction, and time cycle reduction projects.
  • Quality Assurance: Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations, and relevant documents.

Desired Skills and Qualifications:

  • Expertise in Formulation Development: Proficiency in formulation development of various dosage forms with strong knowledge of process optimization.
  • Technology Transfer Experience: Hands-on experience in technology transfer and scale-up.
  • Regulatory Knowledge: Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
  • Analytical and Communication Skills: Excellent documentation, communication, and analytical skills.
  • Project Management: Ability to work in a fast-paced, dynamic environment.
  • Cross-Functional Coordination: Project management and cross-functional coordination.

Qualification and Experience: M Pharm, 12 to 16 years of experience.

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