Tapan Das
Biopharma CMC Exec | Analytical sciences | Drug Product & formulation | Innovation | Protein gene cell vaccine | AAPS Fellow
- Role
- Vice President, Analytical & Quality Control at Spyre Therapeutics
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Tapan Das
Passionate about developing innovative medicines for patients in need. 23+ years of industry experience in biopharma/biotech building high-performing teams. And business strategy, budgeting, portfolio governance, partnering with internal & external stakeholders including CRO/CDMO, and driving progression of clinical pipeline of biologics/ vaccine/ cell/ gene product candidates for development, manufacturing and licensure/commercialization. Technical area interests include product development & manufacturing, biologics analytical and formulation sciences such as phase-appropriate method development, release testing & stability, DS/DP characterization, analytical control strategy, high concentration subcutaneous formulation, prefilled syringe/vial/autoinjector dosage forms, developability/manufacturability, CMC dossier content for IND/BLA/MAA & regulatory technical strategy. Contributed to clinical development of 100+ assets and successful global approval of several major biotherapeutics and vaccines, such as Opdivo®, Empliciti®, Cimzia®, and Opdualag®. Helped 14+ biopharma R&D professionals get promoted into senior-level roles through consistent mentorship and coaching. Led cross-industry consortia and collaborations that resulted in publication of several commentary articles in prestigious journals.
Experience
Vice President, Analytical & Quality Control
Jun 2025 — Present · Princeton, NJ, US
Developing Biologics clinical candidates for Inflammation and Immunology - Analytical Development, Quality Control, High concentration formulation, Patient-friendly dosage forms and dosing regimens.
Education
Tata Institute of Fundamental Research, Mumbai
PhD, Biophysical Chemistry
Albert Einstein College of Medicine
Post doctoral fellow, Biophysics and Protein Stability
Skills
- Biotechnology
- Biopharmaceutical Development and Regulatory Approval
- Formulation and Process
- Biophysical Characterization
- Protein Stability
- Business Strategy
- Management
- Intellectual Property
- Resource Management
- Technology Transfer
- Drug Development
- Glp
- Clinical Development
- Gmp
- Protein Chemistry
- Formulation
- Drug Discovery
- Biophysics
- Biopharmaceuticals
- Pharmaceutical Industry
- Pharmaceutics
- Chromatography
- Drug Delivery
- Pharmaceutical Research
- Purification
- Assay Development
- Uv/Vis
- Pharmacokinetics
- Lc-Ms
- Cancer
- Proteomics
- Biologics
- Analytical Methods Development
- Characterization
- Hplc
- Monoclonal Antibodies
- In Vitro
- Drug Metabolism
- Bioanalysis
- Science
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