Formulation Development Manager

3 days ago

Tiruchi, Tamil Nadu, India beBeePharmaceutical Full time ₹ 1,80,00,000 - ₹ 2,20,00,000
Job Title

Join us in shaping the future of pharmaceutical formulation development.

About the Role

We are seeking an experienced Formulation Development Manager to lead our team in creating innovative and effective manufacturing processes. As a key member of our development team, you will be responsible for designing, optimizing, and scaling up new products while ensuring seamless transitions between development and manufacturing.

Main Responsibilities
  1. Process Design and Optimization: Develop and implement technical improvements for regulated markets (US, Canada, EU) within allotted timelines.
  2. Manufacturing Process Evaluation: Evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
  3. Site Selection: Screen manufacturing sites based on formulation and process complexity/feasibility.
  4. Technology Transfer: Lead technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches.
  5. 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.
  6. SME Guidance: Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  7. Standards Implementation: Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with CFTs.
  8. Capacity Enhancement: Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  9. SOP Review and Approval: 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: Strong knowledge of process optimization and experience in formulation development of various dosage forms.
  • Technology Transfer and Scale-Up: Hands-on experience in technology transfer and scale-up.
  • Regulatory Knowledge: Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
  • Documentation, Communication, and Analytical Skills: Excellent documentation, communication, and analytical skills.
  • Project Management and Cross-Functional Coordination: Ability to work in a fast-paced, dynamic environment and manage cross-functional coordination.
What We Offer

A dynamic and supportive work environment that fosters growth and development. Opportunities for professional advancement and recognition. A competitive compensation package and benefits.

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