Rahul Kalhapure
Somerset,NJ
Summary
“Formulation Scientist” with 13+ years of post-PhD progressive experience, expert in QbD-driven development of multiple complex injectable and ophthalmic drug delivery technologies. A team player with good collaborative, communication, and problem-solving skills with desire to learn, improve and contribute.
Overview
20
20
years of professional experience
Work History
Associate Director- R&D
Odin Pharmaceuticals
Somerset, NJ
07.2024 - Current
- Leading team of 05 scientists for end-to-end development of sterile injectable and ophthalmic drug products.
- Key member of international greenfield manufacturing facility establishment team (equipment selection, FAT, SAT and qualification).
- Successfully delivered 20 plus regulatory filings.
- Providing strategy driven technical leadership to achieve key milestones.
- Collaborating with CFTs to achieve organizational goals.
- Managing drug product CDMOs.
- Technical due diligence of in-licensing products (peptides, oligonucleotides, suspensions and nanoemulsions).
- Preparation of technical documents for pre-NDA, pre-ANDA packages, and responses to IRs, CRLs and DRLs.
- Assessed and approved over 10 plus in-licensing opportunities for complex products.
- NDA and authorship of CMC regulatory filings.
- Mentoring Scientists.
Principal Scientist
Odin Pharmaceuticals
01.2022 - 06.2024
- Scientific leader in end-to-end sterile products development.
- Formulation and process development of complex sterile products using principles of QbD (nanoemulsions, ointments, liposomes, suspensions, lyophilized products, sensitive small molecules, peptides, LAI, gels, non-biological complex molecules, and drug device combination products).
- Selection of new product portfolio for in-house and external development.
- Mentoring scientists at various stages of product development.
- Execution of scale up, engineering and registration batches in-house and at external CMOs.
- Review of batch records, PDRs and supporting regulatory filings.
- Understanding and application of ICH, FDA, and USP guidelines for product development.
- Proposing and delivering innovative approaches to achieve project goals.
- Dealing with vendors on various aspects related to product specific needs, delivery schedules, and cost management.
- Working in a cross functional environment with management, BD, sourcing, QA, R&D, QC, engineering, regulatory, microbiology, and production teams to achieve key milestones.
Senior Scientist II
Odin Pharmaceuticals
Somerset, NJ
01.2019 - 12.2021
- Identified and procured laboratory equipment for manufacturing process development and analysis of complex injectable and ophthalmic drug products.
- Designed and executed R&D batches using DoE, based on scientific literature/patent search, CQAs, and CPPs affecting product quality.
- Generated, analyzed, and interpreted experimental data to draw scientific conclusions.
- Evaluated, and procured product appropriate APIs, raw materials, and PPMs for lab scale product stability data.
- Manufacturing process optimization, process development and scale-up of sterile drug products.
- Prepared documents for tech transfer and regulatory submissions.
Research Assistant Professor
School of Pharmacy, University of Texas at El Paso (UTEP)
TX
06.2017 - 12.2018
- Established a new drug delivery laboratory in the school.
- Worked on development of novel nano drug delivery systems (ufosomes, SLNs, and PNPs).
NRF-DST Postdoctoral Fellow
University of KwaZulu-Natal (UKZN)
Durban, South Africa
01.2013 - 02.2017
- Established novel drug delivery and biocompatible materials synthesis research laboratory.
- Conceptualized research ideas and secured research grants.
- Chemical synthesis, purification, and characterization of novel biomaterials.
- Designed, developed, and evaluated (in-vitro and in-vivo) injectable and transdermal drug delivery systems (liposomes, LPNPs, SLNs, NEs, PNPs, stimuli-responsive NPs, and lipid-dendrimer hybrid NPs) of antibiotics, antimicrobial peptides, and anti-HIV drugs.
- Performed QSAR, computational analysis and molecular dynamics simulation studies on excipients and nanoparticulate systems.
- Established national and international collaborations.
Associate Scientist
Sampro Organic Research Laboratories
Nashik, MS
07.2006 - 01.2007
- Process chemistry and synthesis of specialty chemicals, drug intermediates and APIs.
Education
Ph.D. - Pharmaceutical Chemistry
Institute of Chemical Technology (UDCT)
12-2012
MS - Pharmaceutical Chemistry
University of Pune
06-2006
BS - Pharmacy
University of Pune
06-2004
Activities
- Member- AAPS
- Member- Topical Advisory panel for the Journal 'Pharmaceutics'
- Scientific Reviewer
- Active reviewer on several peer-reviewed WOS indexed journals such as Acta Biomater., J. Control. Release, Mater. Sci. Eng. C, Pharmaceutics, and Int. J. Pharm. among others.
Selected Research Outcomes
US 11,382,863 B2 'Injectable suspension comprising an insoluble corticosteroid and a soluble corticosteroid.', US 11,400,068 B2 'Liquid ready-to-use formulation of Levothyroxine'., US 11,433,084 B2 'Preparation of microparticulate methylprednisolone acetate suspension'., Radiopharmaceuticals: Status, Regulatory Landscape and Future Perspective, AAPS PharmSciTech, 2026, 27, 03, 117, 10.1208/s12249-026-03346-1, Chemistry and Art of Developing Lipid Nanoparticles for Biologics Delivery: Focus on Development and Scale-Up, Pharmaceutics, 2024, 16, 1, 131, https://doi.org/10.3390/pharmaceutics16010131, Nanocrystals for controlled delivery: state of the art and approved drug products, Expert Opin. Drug Deliv., 2022, 19, 1303-1316, Liposomes with pH responsive 'on and off' switches for targeted and intracellular delivery of antibiotics, J. Liposome Res., 2021, 31, 45-63, https://scholar.google.com/citations?user=qslk8wQAAAAJ&hl=en, https://www.webofscience.com/wos/author/record/41402575
Personal Information
Citizenship: USA
Timeline
Associate Director- R&D
Odin Pharmaceuticals
07.2024 - Current
Principal Scientist
Odin Pharmaceuticals
01.2022 - 06.2024
Senior Scientist II
Odin Pharmaceuticals
01.2019 - 12.2021
Research Assistant Professor
School of Pharmacy, University of Texas at El Paso (UTEP)
06.2017 - 12.2018
NRF-DST Postdoctoral Fellow
University of KwaZulu-Natal (UKZN)
01.2013 - 02.2017
Associate Scientist
Sampro Organic Research Laboratories
07.2006 - 01.2007
Ph.D. - Pharmaceutical Chemistry
Institute of Chemical Technology (UDCT)
MS - Pharmaceutical Chemistry
University of Pune
BS - Pharmacy
University of Pune