Formulation Development Lead

8 hours ago

Dombivli, Maharashtra, India beBeeFormulation Full time ₹ 25,00,000 - ₹ 50,00,000
Pharmaceutical Process Development Lead

We are seeking a highly experienced professional to lead our formulation development and research efforts.

The ideal candidate will have a strong background in pharmaceutical process development, with expertise in designing and optimizing manufacturing processes for regulated markets. They will be responsible for developing and implementing technical improvements to manufacturing processes, evaluating process performance using Design of Experiments (DoE) and Quality by Design (QbD) principles, and leading technology transfer functions to ensure successful scale-up of new products.

  • This role involves developing and implementing effective manufacturing strategies to meet regulatory requirements.
  • The selected candidate will have hands-on experience in technology transfer and scale-up, as well as a strong understanding of regulatory guidelines such as USFDA, EMA, and WHO.

To be successful in this position, the candidate should possess excellent documentation, communication, and analytical skills, with the ability to work in a fast-paced, dynamic environment.

Key Responsibilities:

  1. Develop and implement technical improvements to manufacturing processes.
  2. Evaluate manufacturing processes using DoE and QbD principles.
  3. Screen manufacturing sites based on formulation and process complexity/feasibility.
  4. Lead technology transfer functions.
  5. Define procedures for seamless product transfers between development and manufacturing.
  6. Serve as Subject Matter Expert (SME) for pharmaceutical processes and technologies.

Required Skills and Qualifications:

  • Expertise in formulation development of various dosage forms.
  • 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.

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