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.

Senior Manager - Program Manager