Pranav Kalelkar
Process Development Senior Scientist at Amgen
- Role
- Process Development Senior Scientist at Amgen
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Pranav Kalelkar
Scientist with an extensive experience in process engineering and new product development. Has a 10+ years of experience in formulation development and process characterization of a broad range of parenteral modalities – small molecules, peptides and biologics from preclinical to late stage. Has a strong research background in the development of alternate delivery technologies – hydrogels, LPNs, dry-powder inhalable, and SubQ injectables. A 6+ years of successful managerial experience – 2 co-authored publications with the team. Proven record of scientific scholarship – 12 publications in high impact journals- Nature Reviews Material, Science Advances, Small, Biomaterial, Advanced Healthcare Material to name a few. Expertise in authoring regulatory documents DP- related MA sections and has led initiatives on AI-based automation of regulatory authoring process. Editor of American Journal of Polymer Science and Technology. Reviewer of scientific journals such as ACS Omega, Biomaterials and Journal of Polymer Science. Mentor of PhD Student in NIH-T32 Cell and Tissue Engineering Training Program
Experience
Process Development Senior Scientist
Jul 2023 — Present · Cambridge, MA, US
Pivotal Drug Product Technologies• Process development: Extensive experience in process development of biologics. Led studies including commercial formulation development; process characterization (Process challenge study, End-use study, material contact study) and developmental studies. Expert in data analysis, statistical modeling; Characterization (HPLC, CE, particle characterization, rheology, protein concentration); support clinical, engineering and PPQ runs• SME- End-use microbial challenge SME; End-to-End Regulatory Content Automation (RCA) initiative- DP SME • Authoring: Report, protocol, regulatory documents (CTA, MA) DP sections- 32P22, 32P23 and 32P26• Leadership: DPT Lab Captain; Ignite Mentor• Excellent collaborator with team leaders of diverse background: attribute science (AS), drug substance (DS), cellular Sciences, and manufacturing teams to meet deliverables on time
Education
Georgia Institute of Technology
Doctor of Philosophy - PhD, Chemistry
Institute Of Chemical Technology
Bachelor's Degree, Pharmaceutical Sciences
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