Chief Formulation Strategist

2 weeks ago

Rajkot, Gujarat, India beBeeFormulation Full time ₹ 1,80,00,000 - ₹ 2,20,00,000
Job Summary:

We are seeking an accomplished Formulation Development Manager to lead our formulation technology transfer activities. This is a challenging role that requires strong technical expertise, effective communication skills, and the ability to drive process optimization and capacity enhancement initiatives.

About The Role:

In this key position, you will be responsible for developing and optimizing manufacturing processes for regulated markets (US, EU) with technical improvements within allotted timelines. You will also evaluate manufacturing processes using Design of Experiments (DoE) and Quality by Design (QbD) principles to define design space, control strategy, critical/key parameters, and identify process risks.

You will screen manufacturing sites based on formulation and process complexity/feasibility, lead technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches within stipulated time. Additionally, you will define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.

This role demands a high level of technical expertise in pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply. As a SME, you will serve as a point of contact for formulation technology transfer activities and review/approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations, and relevant documents.

The ideal candidate should possess a strong understanding of regulatory guidelines such as USFDA, EMA, WHO, and have hands-on experience in technology transfer and scale-up. Excellent documentation, communication, and analytical skills are essential for success in this role. Ability to work in a fast-paced, dynamic environment with project management and cross-functional coordination skills is also required.

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