Job Description
Management of site-to-site Technology transfer activities:
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- Conduct regular tech transfer product reviews to assess performance, timelines and milestone achievement against plans across all programs, track adherence and resolve issues, if any.n
- Identify potential risks and critical path activities that can affect the program, and flag them to appropriate stakeholders for mitigation.n
- Ensure appropriate process technology transfer from R&D; team to manufacturing team, Manufacturing to Manufacturing (Different sites) and analytical technology transfer from R&D; to QC team by mapping technology transfer elements, collating information and seamlessly transferring all required data/ information to the manufacturing/QC teams.n
- Liaise with regulatory team for compilation of regulatory submission documents and ensure consolidation of submission package as per regulatory checklist, by collaborating with cross-functional teams.n

nManagement of Devices across the portfolio:
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- Understand and maintain the requirement of devices across the portfolio.n
- Co-ordination between R&D;, QC, manufacturing site and Global Purchase operations in device evaluation, finalizationn
- SPOC for CMOs during the device development stagen
- Lead the discussion with Legal, GPO, R&D;, manufacturing and CMOs on CDA/NDA, development agreement and supply agreement.n
- Identify potential risks and critical path activities that can affect the program, and flag them to appropriate stakeholders for mitigation.n

nEnd to end handling of Global program:
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- Lead cross-functional biosimilar programs involving R&D;, CMC, Analytical, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and Commercial functions.n
- Develop and manage integrated program plans, timelines, budgets, and risk registers.n
- Track milestones across cell line development, process development, comparability, clinical studies, and regulatory filings.n
- Ensure program delivery

📌 Senior Manager (Pune)
🏢 LUPIN
📍 Pune