Senior Formulation Development Manager

1 week ago


Mount Abu, Rajasthan, India beBeeDevelopment Full time ₹ 15,00,000 - ₹ 20,00,000
Job Summary

This is a key role within our organization, responsible for leading the formulation development and research department. The ideal candidate will possess expertise in formulation development, technology transfer, and regulatory guidelines.

Key Responsibilities
  • Process Optimization: Develop and implement manufacturing processes using design of experiments and quality by design to define design space, control strategy, critical/key parameters, and identify process risks.
  • Manufacturing Site Evaluation: Assess manufacturing sites based on formulation and process complexity/feasibility.
  • Technology Transfer: Lead technology transfer function with project management skills to ensure successful scale-up of new products and effective launches.
  • Product Transfers: Establish procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  • SME Pharmaceutical Processes: Serve as subject matter expert for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations.
  • Standards Implementation: Define and implement standards for formulation technology transfer and be the point of contact for formulation technology transfer activities.
  • Capacity Enhancement: Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • SOP Review: Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines.
Required Skills and Qualifications
  • Formulation Development: Expertise in formulation development of various dosage forms with strong knowledge of process optimization.
  • Technology Transfer: Hands-on experience in technology transfer and scale-up.
  • Regulatory Guidelines: Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
  • Soft Skills: Excellent documentation, communication, and analytical skills, ability to work in a fast-paced, dynamic environment, project management, and cross-functional coordination.
Benefits
  • Opportunity to work in a fast-paced environment with a team of experts.
  • Professional growth and development opportunities.
  • Competitive compensation package.


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