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Chat NowPURPOSE Lead for vaccine process development, scale the function in accordance to the divisional requirements Thorough understanding of regulatory and GMP regulations and critical quality attributes for Vaccine Development With the objective of developing the processes for vaccines and tech transfer for manufacturing and licensing AREAS OF RESPONSIBILITY (AOR) Direct the overall activities of the upstream process development "• Conceptualizes the overall plan and goals for the function • Develops long term / short term implementation plans for the function in line with PD, CD and program strategy • Guide the design and development (protocol, execution, reporting, and approval) of vaccine process which meets the global expectations by anchoring the functional reviews. • Guide the function in order to create scientific reports of global quality and as per regulatory standards • Provide technical direction and guidance to team IN ORDER TO deliver optimal results People Management "• Effectively Manage delivery of multiple process development projects • Responsible for building of entire function by hiring right people and providing projections for future hiring IN ORDER TO smooth running of the function. • Collaborate with several stakeholder within and across functions to meet the project timeline and deliverables • Coaches GLs/ TLs and TMs for building improvising effectiveness • Provides opportunity for developmental and learning need for every member of the function " Technical Guidance and value addition "• Reviews technical, functional and strategy documents with respect to regulatory guidelines and deliverables • Scans and monitors external environment for technological advancements • Assesses existing processes vis-à-vis external benchmarks and best industry practices IN ORDER TO build-in quality in process development as per global standard • Keeping abreast with the latest technologies Provide guidance to the function to evaluate and adopt new state-of-the art technologies IN ORDER TO create new technology platforms in product development." Accountability of workspace (Shop floor, Safety Quality) " Assume ownership of workspace culture IN ORDER TO ensure safe shop floor with highest quality deliverables • Create work design which improves the work efficiency and quality • Build safety culture across the function." Organizational deliverables " Assists business heads for organizational deliverables • Provide support in the evaluation of external expertize for business input • Discuss opportunities, roadblocks and progress in Apex meetings " Work Experience MINIMUM REQUIREMENTS Education Qualifications Ph.D. in Biology, Chemical Engineering, Microbiology, Biotechnology, Biochemistry, Biochemical Engineering or other related disciplines of engineering or life sciences. Experience Ph.D. with 10+ Years of relevant industrial experience. Business Understanding "Exhibits good understanding of business and industry related to work area. In-depth understanding of cell culture process development for vaccines. Current trends in the Biopharma industrry and in-depth understanding of regulatory framework and IP landscape
25 lakhs to 35 lakhs PA
Pharmaceutical Product Development is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. In December 2021, PPD became a wholly owned subsidiary of Thermo Fisher Scientific.?