S Prasad Peri

AVP GRA Devices, Diagnostics and Digital Health @ Eli Lilly and Company

About

Experienced People and Project Manager with a demonstrated history of working in the regulated pharmaceutical industry and the FDA in the CMC and Combination Product arena.

Country

United States

City

Greater Philadelphia

Industry

Pharmaceuticals

Skill

FDA, Pharmaceutics, Chromatography, Protein Chemistry, Drug Delivery, Drug Development, Regulatory Affairs, Pharmaceutical Industry, Chemistry, Regulatory Submissions, Analytical Chemistry, GMP, HPLC, Technology Transfer, Validation, Biotechnology, Clinical Trials, Protein Purification, Pharmacology, Organic Chemistry

Experience

AVP GRA Devices, Diagnostics and Digital Health

Eli Lilly and Company

2023-4 - Present · 3 yrs 6 mos

Indianapolis, Indiana, United States

Senior Director Regulatory Affairs CMC (Small Molecules, Biologics and Combination Products)

Teva Pharmaceuticals

2015-12 - 2023-4 · 7 yrs 5 mos

West Chester, Pennsylvania, United States

Director

Merck

2014-6 - 2015-12 · 1 yr 7 mos

West Point, PA

Combination Products-Biologics, Devices, Human Drugs and Pharmaceuticals

Branch Chief, ONDQA, CDER, FDA

U.S. Department of Health and Human Services (HHS)

2011-4 - 2014-5 · 3 yrs 2 mos

Review and Assessment of INDs, NDAs, Combination Products supporting the clinical divisions of Pulmonary, Allergy, Rheumatology, Anesthesia, Analgesia, Addiction, Metabolic and Endocrine Products. Reviewed and managed in house consults supporting Antiviral, Cardiovascular, Neurological, Psychiatry drug products, drug-device combinations, and biologics-device combinations, combinations. FDA Liaison for the USP Aerosols Expert Committee and Small Molecules 4 Expert Subcommittee. Research projects in collaboration with FDA Laboratories in St. Louis and National Institute for Pharmaceutical Technology and Education (NIPTIE)

Acting Branch Chief

FDA

2009-10 - 2011-4 · 1 yr 7 mos

Review and Assessment of INDs, NDAs, Combination Products supporting the clinical divisions of Pulmonary, Allergy, Rheumatology, Anesthesia, Analgesia, Addiction, Metabolic and Endocrine Products.

Pharmaceutical Assessment Lead

FDA

1999-6 - 2005-10 · 6 yrs 5 mos

Biochemist

Abbott

1998-8 - 1999-6 · 11 mos

Worked as a contractor for Abbott Labs in the Protein Purification and Development Biochemist. Developed chromatographic methods for isolating several proteins and antigens.