Management of site-to-site Technology transfer activities: /n /n

- 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 /n Management of Devices across the portfolio: /n /n

- 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, finalization

/n

- SPOC for CMOs during the device development stage

/n

- 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 /n End to end handling of Global program: /n /n

- 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 in line with agreed scope, timelines, cost, and quality objectives.

/n

- Act as the primary interface between functional teams and senior leadership.

/n

- Drive program governance through core team meetings, stage gate reviews, and executive updates.

/n

- Resolve cross-functional dependencies and proactively manage conflicts, constraints, and resource risks.

/n

- Ensure alignment with global biosimilars strategy and portfolio priorities.

/n

- Coordinate biosimilar development strategies in line with global regulatory requirements (US FDA, EMA, MHRA, WHO, and emerging markets).

/n

- Support planning for global submissions (e.g., BLA, MAA) including data readiness and submission sequencing.

/n

- Align development plans with target market access and commercialization timelines.

/n

📌 Senior Manager - Program Manager (Pune)
🏢 LUPIN
📍 Pune