Location
Secunderabad | India
Job description
- Opportunity to work with the market leaders in the domain
- Opportunity to initiate & drive a positive global impact
Job Description
- 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.
The Successful Applicant
- 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
What's on Offer
Opportunity to work with the market leaders to contribute positively to the industry and make a global impact
Job tags
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