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Bioprocess Manager

Recombinant Protein Biopharmaceutical Plant, near Mumbai

This position of Bioprocess Manager will handle complete upstream & downstream bioprocess, technology transfer, lead the bioprocess team, implement process improvements, scale up and production of recombinant microbial proteins and antibodies. He will be responsible for production of materials for tox studies, process scale up, and transfers of processes to clinical and commercial manufacturing scales, running production target of the plant and troubleshooting.

Requirements: The candidate will have a Masters or PhD degree in Life sciences, Biotechnology or Chemical engineering, with 8 to 10 years of relevant industry experience.

Manager QA/QC

Recombinant Protein Biopharmaceutical Plant, near Mumbai

The candidate will manage laboratory staff and provide subject matter expertise for laboratories, personnel, instruments, equipment, data systems, and the overall organization. Conduct and lead Bioassays, Product testing, Analytical procedures, Biopharmaceutical and Pharmaceutical tests as per regulatory requirement, IQ/OQ/PQ and documentation, and manage quality related aspects. He will provide strategic and technical input into standard and best practices for the laboratories, ensure equipment, ancillary systems, and processes meet all pertinent regulations and guidance documents. Promote Site EHS Policies and assist with establishing & maintaining safe work standards in the laboratory. Ensure laboratory decisions align with Quality System, GMP and other regulatory requirements, as appropriate. Author and approve protocols, reports and data summaries. Collaborate with research & development and regulatory affairs to support regulatory filings.

Requirements: The candidate will have a Masters or PhD degree in Life sciences, Biotechnology or Analytical Biochemistry/Chemistry, with 8 to 10 years of relevant industry experience.

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