Senior Manager - Program Manager

Lupin; Pune District; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Lupin is seeking a Program Manager to oversee global biosimilar development, coordinating technology transfer across R&D, manufacturing, and QC across multiple sites in India and beyond.

You will drive end-to-end program plans, timelines, budgets, risk registers, and ensure alignment with regulatory requirements (US FDA, EMA, MHRA, WHO) and market access strategies.

Responsibilities

• Manage site-to-site technology transfer activities, tracking timelines and milestone achievement.
• Coordinate regulatory submissions and compile documentation per regulatory checklists.
• Liaise with R&D, QC, manufacturing, and CMOs on CDA/NDA and supply agreements.
• Lead cross-functional biosimilar programs across R&D, CMC, Regulatory, Quality, Manufacturing, and Commercial teams.
• Develop integrated program plans, budgets, and risk registers; ensure on-time delivery.
• Align development plans with market access and commercialization timelines.
• Drive governance with core team meetings and stage-gate reviews; resolve cross-functional conflicts.

Job description

Management of site-to-site Technology transfer activities:

• 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.
• Identify potential risks and critical path activities that can affect the program, and flag them to appropriate stakeholders for mitigation.
• 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.
• 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.

Management of Devices across the portfolio:

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

End to end handling of Global program:

• Lead cross-functional biosimilar programs involving R&D, CMC, Analytical, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and Commercial functions.
• Develop and manage integrated program plans, timelines, budgets, and risk registers.
• Track milestones across cell line development, process development, comparability, clinical studies, and regulatory filings.
• Ensure program delivery in line with agreed scope, timelines, cost, and quality objectives.
• Act as the primary interface between functional teams and senior leadership.
• Drive program governance through core team meetings, stage gate reviews, and executive updates.
• Resolve cross-functional dependencies and proactively manage conflicts, constraints, and resource risks.
• Ensure alignment with global biosimilars strategy and portfolio priorities.
• Coordinate biosimilar development strategies in line with global regulatory requirements (US FDA, EMA, MHRA, WHO, and emerging markets).
• Support planning for global submissions (e.g., BLA, MAA) including data readiness and submission sequencing.
• Align development plans with target market access and commercialization timelines.