Arindam Roy
Biopharma Quality Leader | Manufacturing & Global CMO Networks | AI, Digital Quality & Risk-Balanced Compliance | Transforming Quality from Compliance to Competitive Advantage
- Role
- Head, Cell Therapy Drug Product External Manufacturing & Vector (Internal & External) Quality at Bristol Myers Squibb
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Arindam Roy
Quality-driven Biopharma Leader | 23+ Years Experience | Biologics, Cell Therapy, Small Molecules, Vaccines A passionate advocate for delivering safe, innovative, and best-in-class products, with extensive experience leading multidisciplinary teams to foster strong quality cultures, digital transformation, and risk-based strategies across global operations. Proven expertise in navigating complex technical and manufacturing challenges as well as regulatory inspections, with a track record of collaborating effectively with global stakeholders to bring patient-focused solutions to market. Committed to continuous learning, innovation, and ensuring quality and patient safety remain at the core of every initiative.
Experience
Head, Cell Therapy Drug Product External Manufacturing & Vector (Internal & External) Quality
Oct 2023 — Present
Education
Jadavpur University
M.Sc, Organic Chemistry
Indian Institute of Technology, Delhi
M.Tech., Modern Methods of Chemical Analysis
Jadavpur University
B.Sc, Honors in Chemistry
Missouri University of Science and Technology
Ph.D., Analytical Chemistry
Skills
- Hplc
- Glp
- Usp
- Characterization
- Technical Writing
- Organic Chemistry
- Quality Control
- Gmp
- Protein Chemistry
- Gc/Ms
- Cgmp
- Process Development
- Laboratory
- Drug Development
- Biopharmaceuticals
- 21 Cfr Part 11
- Chromatography
- Lims
- Chemistry
- Biotechnology
- Structure Elucidation
- Wet Chemistry
- Regulatory Submissions
- Product Development
- Technology Transfer
- Research
- Quality System
- V&V
- Process Simulation
- Drug Discovery
- Quality by Design
- Validation
- Mass Spectrometry
- Uv-Vis
- Science
- Uv/Vis
- Gc-Ms
- Quality Assurance
- Capa
- Pharmaceutical Industry
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