VP R&D, Vaccinations

• Overall responsibility for the developmental projects (Human Vaccines, Veterinary Vaccines & Biologicals).
• Co-ordinating overall developmental activities of different vaccines under development human & veterinary vaccines, to plan, control and manage developmental to meet the project time lines.
• Ensuring compliance of various developmental activities (People, Product, Process, Documents and Facility) to relevant quality standards and regulatory requirement.
• Oversee technology transfer of new vaccines from R&D to manufacturing and maintaining timelines for introducing new products.
• Resource planning, optimisation, and utilisation to ensure timely delivery of the developmental projects.
• Accessing the skills, competency of individuals on continuous basis and organising suitable trainings for improvement.
• Responsible for the various statutory approvals like IBSC, IEAC and RCGM and other Regulatory Approvals as applicable.
• Writing research grants to national and international agencies, defend and present data and business case.
• Remain as key scientific and technical face of the company
• Manage and handle CAPEX, OPEX and manpower budget of R&D organization.

• Sc./ M. Pharm/ M.Tech/ M.V.Sc/ B.Tech (Biotechnology / Microbiology / Biochemistry)
• D. in life sciences is preferred

• Minimum of 20 years of experience at middle management position in reputed Biologics/vaccines in Research & Development role.
• Should have good knowledge about process development that involve cell culture, virus culture, bacterial fermentation, Purification methods and formulation of vaccines.
• Assessment of technology transfer protocols and process development reports and
• Experience in risk-based assessment of various developmental projects.
• Should be well versed with India and overseas regulatory requirements.
• Good knowledge on manufacturing requirements for WHO PQ process.
• Should be aware of pharmacopoeia requirements on vaccines and biologicals.
• A proactive approach to all aspects of developmental activities including DOE, Process validation & Process control and analytical method qualification and validation.
• Coordination with internal stake holders (Quality, Manufacturing, Engineering, etc.) and external stake holders (regulators, auditors, business partners, etc.) is required.
• Good exposure to quality fundamentals including Change controls, deviations, OOS and CAPA.
• Experience in LIMS environment and exposure to statistical and data analytical tools.
• Strong IT skills, big data analysis, statistical interpretation.
• Good Project management (time, budget, and resource planning) skills.
• Set up and manage external collaborations. Coordinate with external partners or CROs to accelerate the development programs

Michael Page