Vinai Unnikrishnan
Director Ms & t @Adaptimmune
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WORK HISTORY
Director Ms & t @Adaptimmune
Abingdon, GB
Vector Technical Lead for Tecelra®, the world’s first modified TCR cell therapy; manage viral vector process development, transfer, and GMP readiness across three international manufacturing sites.Oversaw introduction and scale-up of 8 distinct lentiviral vector (LVV) products, utilizing both suspension and adherent processes across global sites.Directed regulatory strategy and authored Module 3 content for multiple INDs and BLAs, including Tecelra® and upcoming filings in Europe. In addition, I am currently responsible for the technical process leadership and BLA readiness for a second gene therapy product, with a planned regulatory submission in 2025.Managed technology transfer of viral vector, plasmid, and allogeneic processes to both internal GMP facilities and external CDMOs, ensuring regulatory compliance and performance standards.Led successful MHRA and FDA inspections (2019, 2023, 2024) for novel vector manufacturing platforms and commercial-readiness audits.Built and scaled a 20-person cross-functional team for viral vector manufacturing excellence, embedding CPV and QbD principles.Established a centralized framework for plasmid manufacturing management across multiple complex platforms and CDMO sites.Responsible for aseptic process validation and simulation strategy for all UK-based manufacturing sites.
EDUCATION
University of Essex
MSc, Biotechnology
SKILLS
ABOUT VINAI UNNIKRISHNAN
Strategic biotech leader with over 20 years industry experience leading Manufacturing Science & Technology (MS & T) across full product lifecycle for multiple cell therapy platforms, specializing in viral vector processes and technical management experience in plasmid, and allogeneic manufacturing. As the Vector Technical Lead for Tecelra®, the world’s first modified TCR gene therapy, I have the insight of unique challenges and experience leading it from development through global tech transfer, characterization, GMP scale-up, BLA submission and getting it across the finish line as a commercially available treatment. With deep expertise in technology transfer, process validation, and regulatory strategy, I’ve led technical operations across continents, managed innovation driven projects, fostering high-performing cross-functional teams, and delivered on complex IND, IMPD, and BLA filings with multiple regulatory agencies (MHRA, EMA, FDA).Alongside my scientific and operational background, I’m also deeply passionate about using AI to enhance productivity, decision-making, and innovation in biotech. I have advanced knowledge of AI tools and prompt engineering, and apply them to accelerate tech transfer documentation, regulatory writing, and cross-functional collaboration.
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