Nishan Shah
Sr. Manager - Drug Product Development, at Arranta Bio
- Role
- Sr Manager - Drug Product Development at Recipharm Advanced Bio
- Location
- Woburn, MA, US
- LinkedIn followers
- 500 followers
About Nishan Shah
Team first, goal oriented, and passionate scientist specializing in drug product design, and experimental design. Experience in: Lipid nanoparticle, and polymeric nanoparticle drug delivery systems, spray drying, analytical chemistry, solid state and pre-formulation characterization, powder characterization, DoE, QbD, oligonucleotide drug product design/development, live-biotherapeutic drug product design/development, technical writing, mentorship, and leadership
Experience
Sr Manager - Drug Product Development
May 2021 — Present · Watertown, MA, US
Design and implementation of robust, scalable, and translatable platforms for nucleic acid and microbiome modalities: drying technologies, lipid nanoparticles, equipment design • Led the design and development of nucleic acid and microbiome drug product units • Collaboration with business unit and upper management on drafting of contracts • Lead collaborative efforts with neighboring departments (process engineering, analytical development, drug substance, manufacturing) • Experienced in technical documents: SOPs, protocols, batch records, technical reports, process descriptions • Lead process development representative for technical transfer from process development laboratories into non-GMP and GMP manufacturing (drug product) • Proficient in design of experiment, quality by design, statistical analysis • Lead scientific and team driven discussions with colleagues, clients, and other stakeholders as drug product subject matter expert • Overseeing of day-to-day operations of drug product development laboratories (nucleic acids, microbiome) • Mentorship, training, and guidance of younger scientists, associate scientists, technicians
Education
University of Rhode Island
Doctor of Philosophy - PhD, Biomedical and Pharmaceutical Sciences, 3.80/4.0
2015 — 2019
University of Rhode Island
Bachelor's degree, Biological Sciences, 3.46/4.0
2010 — 2015
University of Rhode Island
Bachelor's degree, Pharmaceutical Sciences, 3.46/4.0
2010 — 2015
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