Bharat Gurale

About Bharat Gurale

I am a Senior Principal Scientist and Process Chemistry leader with 15+ years of experience spanning foundational academic research and industrial leadership in the CDMO/CMO sector. My core expertise lies in designing and implementing robust, scalable synthetic routes for structurally complex small‑molecule APIs and ADC payload‑linkers.In my current role, I serve as a primary technical partner for pharmaceutical CMC teams, bridging discovery chemistry and commercial manufacturing. I lead phase‑appropriate process development from preclinical route scouting through Phase PPQ and commercial launch, with a focus on delivering “first‑time‑right” outcomes through rigorous impurity fate‑and‑purge strategies, crystallization and solid‑form development, and reliable technology transfer. I provide comprehensive oversight of the drug substance lifecycle, managing internal laboratory teams and plant production while coordinating with external CDMOs and international sister sites to ensure seamless supply of GMP starting materials, intermediates, and APIs.Beyond the plant floor, I am an active contributor to the scientific community as a peer reviewer for major journals (including ACS and RSC titles) and as an editorial board member for open‑access chemistry journals. This dual perspective helps me translate cutting‑edge scientific advances into practical, scalable manufacturing solutions.Core areas of expertise:• Technical leadership: route scouting, process characterization, and scale‑up (gram to multi‑kg / metric‑ton).• Operational oversight: managing internal R&D teams, tech transfer to GMP production, and multi‑site CDMO/vendor coordination.• CMC and regulatory support: technical input and review for IND, IMPD, NDA, and DMF drug substance sections; ICH‑ and USP‑aligned control strategies.• Specialized chemistry: ADC payload‑linker development and high‑potency API (HPAPI) manufacturing.• Quality and risk: QbD, PRA/FMEA, DOE‑driven optimization, and root‑cause analysis/CAPA for manufacturing deviations.

Experience

1. Manager, Research & Process Development Principal-level Process Chemist

   Piramal Pharma Solutions

   Apr 2021 — Present · Riverview, MI, US

   End-to-End Process Development: Lead development and scale-up of structurally complex small-molecule APIs and ADC payload-linkers, advancing programs from route scouting (gram scale) through multi-kilogram commercial manufacturing.• Route Design & Process Robustness: Design practical, safe, and economically viable synthetic routes with strong emphasis on Quality by Design (QbD), impurity fate-and-purge strategy, and cGMP compliance.• Hands-On Technical Leadership: Maintain active laboratory engagement while working cross-functionally with Analytical, QA/QC, Engineering, and Manufacturing to transition processes from R&D to validated commercial operations.• Regulatory & Validation Contributions: Supported programs across Phase development; contributed to authoring and technical review of IND, IMPD, and NDA documentation, including process validation packages.• External Manufacturing Interface: Partner with external CDMOs and global sites for GMP starting materials and advanced intermediates, ensuring technical alignment, quality oversight, and supply continuity.

Education

• Swami Ramanand Teerth Marathwada University (SRTMU), Nanded

  Bachelor of Science - BS, Chemistry Botany Zoology

• Pune University

  Ph.D., Synthetic Organic Chemistry, Natural Product Synthesis

  2012

• Swami Ramanand Teerth Marathwada University (SRTMU), Nanded

  Master of Science (M.Sc.), Organic Chemistry

Skills

• Organic Chemistry
• Synthetic Organic Chemistry
• Drug Discovery
• Organic Synthesis
• Medicinal Chemistry
• Drug Design
• Spectroscopy
• Nmr
• Purification
• Chemistry
• Characterization
• Heterocyclic Chemistry
• Chromatography
• Hplc
•  Natural Product Synthesis  Medicinal Chemistry  Inositol and Carbohydrate Ch
• Lc-Ms
• Nucleosides/Nucleotides Synthesis
• Mass Spectrometry
• Nuclear Magnetic Resonance (Nmr)
• High-Performance Liquid Chromatography (Hplc)
• Laboratory Skills
• Pharmaceutical Industry
• CRO Management
• Gc-Ms
• Research and Development (R&D)
• Gmp
• Dna
• Drug Development