Senior Formulation Development Manager

1 day ago

Salem, Tamil Nadu, India beBeeFormulation Full time ₹ 24,00,000 - ₹ 28,00,000
Job Title:

Senior Formulation Development Manager

Job Description:

We are seeking a highly skilled and experienced Senior Formulation Development Manager to join our team. In this role, you will be responsible for developing and optimizing manufacturing processes with technical improvements for regulated markets within allotted timelines.

Key Responsibilities include:

  • Developing and optimizing manufacturing processes with technical improvements for regulated markets within allotted timelines.
  • Evaluating manufacturing processes using Design of Experimentation (DoE) and Quality by Design (QbD) principles to define design space, control strategy, critical/key parameters, and identify process risks.
  • Screening manufacturing sites based on formulation and process complexity/feasibility.
  • Leading technology transfer functions to ensure successful scale-up of new products and effective launches within stipulated time.
  • Defining procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
  • Providing subject matter expertise for pharmaceutical processes and technologies, offering guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
  • Establishing and implementing standards for formulation technology transfer and serving as the point contact for formulation technology transfer activities.
  • Initiating and driving capacity enhancement, cost reduction, and time cycle reduction projects.
  • Reviewing and approving departmental Standard Operating Procedures (SOPs) to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations, and relevant documents.

Requirements:

  • 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 USFDA, EMA, and 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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