Jayshree Patel, Ph.D., is a leading Subject Matter Expert in Microbiology at NAMSA, where she is leading initiatives to expand service areas and revenue, with a focus on microbiology and regulatory compliance. Dr. Patel has dedicated 23 years to helping medical devices and pharmaceutical clients navigate complex microbiological challenges and achieve regulatory approval.
Dr. Patel’s expertise is rooted in a deep understanding of global regulations, and she is technical expert representing NAMSA in technical committees such as AAMI, ISO, USP, PDA. Prior to her role at NAMSA, she Led and Managed bioassay development for Pharmaceuticals, Medical Device, Biologics at various CDMO/CTDMO and built strong relationships with potential/existing clients.
A respected authority in the field, Dr. Patel, published impactful findings on discovery of antibiotic/anticancer biomolecule from natural sources as evidence of 13 first-authored publications in a peer-reviewed journal. She is committed to advancing patient safety by providing rigorous, science-based solutions that meet the evolving demands of global regulatory bodies.
With an MBA in organizational management and leadership, a doctorate in microbiology, and more than 20 years of leadership experience in the pharma and biotech industries, Dr. Patel is a visionary in strategic planning and quality management.
CORE COMPETENCIES
- Experienced communicator of complex topics to diverse audiences as evidence by 3 award winning scientific publication in less than one year while maintaining staller performance at IriSys LLC.
- Extensive knowledge of current regulatory requirements in microbiology testing for biologics, pharmaceuticals, medical devices as well as cleanroom set-up for aseptic operations as evidence by establishing microbiology testing labs and aseptic manufacturing facility at 4 different organizations i.e. IriSys LLC, Recro Pharma, Societal CDMO, and STAAR Surgical.
- Proficient in grasping new concepts and creative problem solver as evidence of resolving critical Outbreak issue in less than 8 months by planning and collaborating with cross-functional diverse groups of national and international corporations at WuXi AppTec.
- Technical expert presenting industry at various technical committee events i.e. Kilmer conference, AAMI working group meetings, PDA regulatory committee etc.
RECENT PROJECTS
- Investigated FDA finding to uncover 10 years of misrepresentation of data for Marietta site disinfection and cleaning programs
- Participated in AAMI WG 08 for reviewing TIR52 (AAMI TIR 52 is a Technical Information Report giving guidance on the routine monitoring of viable (microbial) and non‑viable particulates in controlled environments used in the production of healthcare products intended for terminal sterilization).
- Provided comments and proposed quality improvement criteria for ST90 Annex (ST‑WG‑86 is working on an amendment to ST90). This committee accepted my suggestions, and the first working draft of this amendment was completed on July 31st.
- Working with PDA regulatory Commenting to provide comments on USP <1072> Disinfection and Antiseptics revision and providing comments on behalf of industry.
PUBLICATIONS
- Patel, J.D., and Kahn, G. 2017. Drug approval regulation: The global impacts. Journal of Bacteriology & Mycology: 4(6), 191-192.
- Patel, J.D., Downing, J., and Makhluf, H. 2017. Discovery of Antibiotic Molecule(s): A Multidisciplinary Approaches. International Journal of Current Biochemistry Research. 5(6): 112-118.
- Patel, J.D., and Fadaei R. 2016. Cost of Antibiotics in Society and Economic Approach. IOSR Journal of Economics and Finance. 7(6): 17-20.
- Patel, J.D., Sahay, N.S., and Kumar, V. 2015. Fingerprinting of The Acacia Nilotica (L.) Bark Extract Having Antibacterial Property. Journal of Health Science. 3(3): 132-136
- Patel, J.D., et al. 2014. Dynamism of Antimicrobial Activity of Actinomycetes—A Case Study from Undisturbed Microbial Niche. Advances in Microbiology, 4, 324-334.
- Patel, J.D., Kumar, V., Sahay, N.S., and Bhatt, S.A 2011. Medicinally Important Plant Ocimum Sanctum L.: An Overview. Anarta. 13(1): 148-155.
- Patel, J.D., Shrivastava, A.K., and Kumar, V., 2009. Evaluation of Some Medicinal Plants Used in Traditional Wound Healing Preparations for Antibacterial Property Against Some Pathogenic Bacteria. Journal of Clinical and Immunopathology Research. 1(1):007-012.
- Patel, J.D., Kumar, V., and Bhatt, S.A., 2009. Antimicrobial Screening and Phytochemical Analysis of Resin Part of Acacia Catechu. Pharmaceutical biology. 47(1): 34-37.
- Patel, J.D., Patel, D.K., Shrivastava, A., and Kumar, V., 2008. Screening of Plant Extracts Used in Traditional Antidiarrhoeal Medicines Against Escherichia Coli. Scientific World. 6: 63-67.
- Patel, J.D. and Kumar, V. 2008. Annona squamosa L.: Phytochemical Analysis and Antimicrobial Screening. Journal of Pharmacy Research. 1(1): 34-38.
- Patel, J.D., Shah, K.R., Patel, P.M. and Bhatt. S.A. 2007. Herbal Plants Extract and Its Combination Showing Antibacterial Activity Against Staphylococcus aureus (MTCC 96), Pseudomonas aeruginosa (MTCC 741). Journal of Veterinary Pharmacology and Toxicology. 6:45-53.
- Patel, J.D 2015. Ethnomedicinal Uses and Chemical Constituents of 35 Plants. LAP LAMBERT Academic Publishing. Pp 1-89. ISBN:978-3-659-74965-0
- Patel, J.D. and Kumar, V. 2010. A Thesis Review: Herbal Naïve: Enriched in Curative Possessions.
