Formulation Development and Research Lead

5 days ago

Bharatpur, Rajasthan, India beBeeFormulation Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

**Job Summary:**

We are seeking an experienced professional to lead formulation development and research initiatives.

The ideal candidate will have a strong background in process optimization, technology transfer, and scale-up. They will also possess excellent communication and documentation skills, as well as the ability to work in a fast-paced environment.

**Key Responsibilities:

  • Design and optimize manufacturing processes for regulated markets 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 function with project management skills to ensure successful scale-up of new products and effective launches.
  • 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.
  • Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities.
  • Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • 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 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, 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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