Chief Formulation Development Manager

2 days ago

Panjim, Goa, India beBeePharmaceutical Full time ₹ 18,00,000 - ₹ 20,00,000
Job Title:

We are seeking an experienced manager to lead our formulation development and research team. As a key member of our organization, you will be responsible for designing and optimizing manufacturing processes, evaluating process risks, and ensuring the successful scale-up of new products.

Key Responsibilities:
  • Process Optimization: Develop and implement technical improvements for regulated markets within allotted timelines.
  • Process Evaluation: Use Design of Experiments (DoE) and Quality by Design (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 the technology transfer function with adequate project management skills to ensure seamless product transfers between development and manufacturing.
  • SME Expertise: Serve as Subject Matter Expert (SME) for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations.
  • Standards Development: Define and implement standards for formulation technology transfer and be the point 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.
Desired Skills:
  • 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 Knowledge: Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
  • Documentation: Excellent documentation, communication, and analytical skills.
  • Project Management: Ability to work in a fast-paced, dynamic environment and possess project management and cross-functional coordination skills.

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