QUALIFICATION & EXPERIENCE:

- An advanced degree in pharmaceutical, chemical, biological sciences or engineering is preferred, with at least 20 years of pharma experience. A minimum of 15 years in biologics manufacturing and at least 5 years in a leadership position as Head of Operations.

- Strong technical and leadership experience in biologics drug substance and drug product manufacturing in a cGMP environment is required.

- Proficient in quality and regulatory requirements of various countries like USFDA/ANVISA/INVIMA, especially for biological products.

IDEAL CANDIDATE SHOULD BE:

1) Lead and guide teams across various departments like Production (both bulk and formulations), QA, QC (Biologics, Chemical and Microbiology), Warehouse, and Utilities & Engineering, while maintaining highest levels of regulatory compliance. Hence, should have prior experience of various departmental heads reporting to him in Plant operations in a regulatory compliant environment

2) Strong in implementing regulatory compliance, preferably a person who led such activity from scratch in an earlier assignment

3) Assertive and consultative leadership, than authoritative. Entrepreneurial approach in Targets chasing and deploying resources efficiently

4) Capable of implementing factory security measures, statutory compliance with local governing bodies, waste management, safety of work environment and protection of intellectual property and confidential matters of the company.

RESPONSIBILITIES AND WORK AREAS:

- Oversee all daily operations of the Plant from securing the premises to biologics bulk production to formulation & fill-finish manufacturing, plant utilities, material management, quality control, quality assurance and implementation of quality & safety procedures in a regulatory environment.

- Ensure that plant safety and operational overhead efficiencies are met and continuously strive for improvement. A reasonably good knowledge on machines and related Engineering aspects is essential and should implement measures taking into account environmental awareness, pollution risks, waste management and effluent discharges that comply with the government's pollution norms.

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