Senior Formulation Development Specialist

2 days ago

Kozhikode, Kerala, India beBeePharmaceutical Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Formulation Expert Job Description

Key Responsibilities:

  • Develop and optimize manufacturing processes for regulated markets (US, Canada, EU) within allotted timelines.
  • Evaluate manufacturing processes using Design of Experiments (DoE) and Quality by Design (QbD) to define design space, control strategy, critical/key parameters, and identify process risks.
  • Screen manufacturing sites based on formulation and process complexity/feasibility.
  • Lead technology transfer functions with adequate project management skills to ensure successful scale-up of new products and effective launches with stipulated time.
  • Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  • Serve as Subject Matter Expert (SME) for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  • Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with Cross Functional Teams (CFTs).
  • Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • Review and approve departmental Standard Operating Procedures (SOPs) to ensure compliance with current Good Manufacturing Practice (cGMP) and Customer Quality Assurance (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 US FDA, 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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