Hiren Patel
Innovator in Drug Product Development | Expert in CPV, QbD, and Scale-Up | Delivering Robust Clinical & Commercial Solutions
- Role
- Senior Principal Expert-global Msat at Boehringer Ingelheim
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Hiren Patel
Highly accomplished Pharmaceutical Industry veteran with 15+ years of success, recognized for proficiency in product development and expertise in Chemistry, Manufacturing, and Controls (CMC).• Proficient in various aspects of pharmaceutical manufacturing, including Solid Oral Dosage, Liquid Oral Dosage, and Injectable Dosage Manufacturing.• Extensive knowledge and hands-on expertise in a wide range of pharmaceutical processes, such as controlled-release drug delivery, peptide – protein delivery, single and multi-layer tableting, functional and non-functional film coating, high shear and fluid bed wet granulation, and size reduction for nano suspension.• Played a vital role as a Technical Subject Matter Expert (SEM) in formulation knowledge for formulation development, scale-up, pilot, and commercial plants. Successfully resolved technical challenges, conducted troubleshooting, and led improvement efforts.• Demonstrated proficiency in applying Quality by Design (QbD) concepts throughout the design, execution, and interpretation of formulation and process development experiments.• Proven ability to collaborate effectively with diverse cross-functional teams, spanning different countries and cultures. Worked closely with business, regulatory, clinical, and operational teams within the company, as well as scientific communities and external collaborators.• Possess a comprehensive understanding of US-FDA regulations, ensuring compliance with timelines and industry standards.• Skilled in authoring essential documents such as product development reports, tech transfer documents, risk assessments, and regulatory filing documents, including IND, IMPD, NDA, BLA and ANDA
Experience
Senior Principal Expert-global Msat
Jan 2024 — Present · New Brunswick, NJ, US
Lead technical strategy and lifecycle support for global MSAT and Operations teams, ensuring robust product and process performance from development through commercialization.Provide expert guidance on the adoption of innovative manufacturing technologies, enabling the evolution of next-generation platforms and enhancing scalability and efficiency.Drive cross-functional technical initiatives, delivering high-impact outcomes across diverse project scopes while managing timelines, budgets, and risk.Spearhead technical leadership in root cause investigations, manufacturing deviations, validation strategies, and regulatory responses, including global expansion and post-approval changes.Oversee GMP pilot batch execution, including protocol development, master batch record review, and comprehensive reporting to support regulatory and operational readiness.Champion continuous process improvement by integrating data-driven insights and fostering a culture of innovation and operational excellence.
Education
L.M. College Of Pharmacy
Bachelor's Degree, Pharmacy
2004 — 2008
University of the Sciences in Philadelphia
Doctor of Philosophy (PhD), Pharmaceutical Sciences
2016 — 2022
Fairleigh Dickinson University-Metropolitan Campus
Master's Degree, Pharmaceutical Chemistry
2008 — 2010
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Hplc
- Chromatography
- Organic Chemistry
- Chemistry
- Validation
- Biochemistry
- Uv/Vis
- Regulatory Affairs
- Laboratory
- Ftir
- Gmp
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