Indrajit Ghosh
South Brunswick,NJ
Summary
Accomplished leader in Pharmaceutical Sciences, CMC, and Innovation with over 23 years of comprehensive drug product development experience, encompassing both biologic and small molecules from preclinical stages to market launch. Expertise includes 13 years at BMS/Celgene and 8 years at Novartis, driving global cross-functional teams to execute robust drug product and CMC strategies focused on high-concentration, large-volume subcutaneous delivery systems integrated with advanced devices. Proven ability to translate cutting-edge technologies into actionable CMC strategies while establishing effective externalization models (CDMO/CMO) and delivering governance-ready recommendations that balance risk, timelines, costs, and patient-centric outcomes. Recognized for a strategic mindset that fosters innovation and enhances operational efficiency throughout the product lifecycle.
Overview
21
21
years of professional experience
Work History
Biologics Drug Product Development and Technology Lead (SPDD, GPS)
Bristol Myers Squibb (BMS)
New Jersey
05.2019 - Current
- Directed end-to-end drug product development for biologic (monoclonal antibody, ADCs, fusion proteins), integrating formulation, device/delivery, bio-pharmaceutical, analytical, clinical supply, quality, and regulatory CMC partners from early to late phase.
- Leader of ultra-high concentration technology for the Biologic platform
- 1st time platform development for high-dose monoclonal antibody with high concentration formulation and OBDS
- Owned CMC drug product strategy, integrated work plans, timelines, and risk registers; prepared and delivered governance updates and decision packages for senior stakeholders.
- Led high- and ultra-high-concentration formulation strategy and external technology evaluations to enable large-volume subcutaneous administration of high-dose assets.
- Defined and executed bio-pharmaceutics bridging strategies (in vitro/in vivo, PK, dose linearity, tolerability) to mitigate comparability risks tied to DS process/cell-line changes and formulation/route changes.
- DPDT Lead / Formulation Project Lead (Biologic)
Group Leader / Associate Director / Compound (CMC) Leader (Small Molecules – Oral and Sterile)
Celgene
New Jersey
05.2013 - 01.2019
- Built and led a high-performance PS&T team; managed hiring, resourcing, coaching, and performance processes while supporting high-priority internal and alliance programs.
- Served as Drug Product Development Lead and Compound/CMC Lead across internal and partnered portfolios, ensuring milestone delivery, budget adherence, and integrated risk management.
- Advanced nanotechnology initiatives and supported commercialization, including the transfer of continuous manufacturing and NAB compounding technologies across sites.
- Implemented global externalization strategy for DP CMOs/CDMOs (oral, parenteral, specialized delivery technologies); performed due diligence, site visits, and capability-based partner selection
- Led cross-functional CMC governance endorsements as Compound Leader (part-time rotation, 3 years); managed ~US$5M annual PDT budget (~US$20M over 3 years).
Pharmaceutical Development Project Leader / Principal Scientist for Small Molecule Portfolio
Novartis Pharmaceuticals
East Hanover, New Jersey
01.2005 - 05.2013
- Led drug product development for early- and late-phase programs, ensuring effective transition from development into commercial manufacturing.
- Delivered formulation/process development, scale-up, and technology transfer for multiple NCE and lifecycle management programs, including commercially significant assets and lifecycle work
- Drove patient-centric development and value maximization for an oncology program
- Applied cGMP expertise across internal sites and CMOs; supported inspection readiness and pre-approval activities.
- Pharmaceutical Development Project Leader / Principal Scientist (Drug Product & MS&T)
Education
PhD - Pharmaceutical Science (Nano Drug Delivery)
Rutgers State University
New JerseyMBA - Leadership & Strategic Management
University of Massachusetts
Massachusetts05.
Skills
- High Dose Biologic development: Using high-concentration biologic and high-volume devices via patient preference studies
- Pharmaceutical Technology / MS&T: process development, scale-up, tech transfer, PPQ readiness, clinical & commercial supply support; risk management and control strategy and modeling
- Bio-pharmaceutics & Bridging: PK/tolerability study design; comparability and bridging for DS cell-line changes, formulation changes, and route of administration for Biologic and BCS Class 2/4
- CMC Strategy & Governance: QTPP/CQAs, development plans, tradeoffs with timelines, gated spending, and risk management with governance alignment
- Implementation of Innovation & Enabling Technologies and Operation readiness for portfolio assets: ultra/high-concentration biologic, OBDS, nanotechnology, hot-melt extrusion (HME), FDC
- Externalization & Partnering: CDMO/CMO/CRO strategy, due diligence, capability assessment, and selection (US/EU/APAC) for fit for mapping technology landscape
- People Leadership: team building, coaching, performance management, hiring; culture of science, innovation, and execution as Drug Product Development and CMC leadership Educating GPT and the commercial team, presenting at the CEO LT on new technologies for long-term investment
- Led high-profile drug product teams for biologic (monoclonal antibodies, ADCs, fusion proteins), managing an overall drug product budget of ~US$50M and driving on-time, risk-managed delivery
- Advanced high-dose subcutaneous delivery strategies via high-concentration formulation development, large-volume device (OBDS), and alignment with regulatory requirements for clinical introduction
- Built bio-pharmaceutics and bridging work plans to de-risk DS process/cell-line changes and formulation/route transitions; translated data into governance-ready recommendations
- Designed and proposed an innovation strategy for the introduction of new technology and tech transfer during clinical and also at the post-commercial phase
Affiliations
SC Consortium to align on industry wide roadmap for clinical bridging strategies and buy in from agency
Timeline
Biologics Drug Product Development and Technology Lead (SPDD, GPS)
Bristol Myers Squibb (BMS)
05.2019 - Current
Group Leader / Associate Director / Compound (CMC) Leader (Small Molecules – Oral and Sterile)
Celgene
05.2013 - 01.2019
Pharmaceutical Development Project Leader / Principal Scientist for Small Molecule Portfolio
Novartis Pharmaceuticals
01.2005 - 05.2013
PhD - Pharmaceutical Science (Nano Drug Delivery)
Rutgers State University
MBA - Leadership & Strategic Management
University of Massachusetts
Work authorization
US Citizenship