Anish Nag
Drug Product Development Scientist (Ph.D.) | Analytical Development, CMC & Formulation | LC-MS / Mass Spectrometry (Orbitrap, QToF, HRMS) | Stability, Impurities & Solid Form | Small molecules, RNA, ADCs | Ex-Amgen
- Role
- Process Development Scientist at Amgen
- Location
- Thousand Oaks, CA, US
- LinkedIn followers
- 500 followers
About Anish Nag
Ph.D. analytical chemist and drug product development scientist with four years at Amgen, where my work split evenly between analytical/CMC development and formulation/preformulation. I develop the methods and I develop the formulation, and I am most useful where analytical evidence has to drive a real development decision. At Amgen, in the pre-pivotal Preformulation and Drug Product Technology group (Synthetic Enabling Technologies), I built LC-MS, HPLC/UPLC, and GC-MS methods for stability, impurity, and degradation work; led solid form selection (salt and polymorph screening, including establishing the enantiotropic vs monotropic relationship between two salt crystal forms of a development API); developed oral solid and parenteral formulations; drove bioavailability enhancement with GastroPlus PBPK/DMPK modeling; and contributed IND-supporting CMC analytical documentation for LUMAKRAS (sotorasib), the first-in-class KRAS G12C therapy approved by the FDA. I led the procurement, installation, and validation-readiness of a Thermo Orbitrap Exploris 120 LC-HRMS platform and trained scientists across the organization, and I improved critical-data turnaround by ~75% on annual KPIs through workflow redesign. My technical core: LC-MS/MS, LC-HRMS (Orbitrap), HPLC/UPLC, GC-MS; analytical method development, validation, and transfer; stability, forced degradation, and impurity/degradant profiling; solid-state and physicochemical characterization (PXRD, DSC, TGA, DVS, Karl Fischer, particle size); preformulation, solid form selection, and oral solid and parenteral formulation; GastroPlus modeling; and CMC documentation aligned to ICH Q1, Q2(R2)/Q14, Q3, Q6, and Q7 to Q12. I also bring a strong organic chemistry foundation (Ph.D. multi-step synthesis) and biologics-adjacent and RNA exposure (peptide mapping, intact mass, HIC-based DAR, and postdoctoral RNA therapeutics work at UCLA), plus a record of six peer-reviewed publications, 400+ citations, and peer review for Cell Chemical Biology, Plant Cell, and the Journal of Biological Chemistry. I always welcome opportunities for deep discussions and collaborations on analytical development, CMC, formulation, and drug product development roles, as well as scientific and medical writing roles where deep science meets clear communication.
Experience
Process Development Scientist
Aug 2021 — Present · Thousand Oaks, CA, US
Process Development Scientist in Amgen\'s pre-pivotal Drug Product Technology group.
Education
UCLA
Doctor of Philosophy, Chemistry
Indian Institute of Technology, Kharagpur
Integrated B.S. and M.S., Industrial Chemistry
UCLA
Master of Science, Organic Chemistry
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