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.
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