Amita Sachdeva
Belmont,MA
Summary
Analytical Scientist with extensive experience supporting biologics and vaccine development, specializing in analytical method design, qualification, and troubleshooting in accordance with ICH Q2(R2). Deep expertise in chromatography (RP-HPLC/UPLC, SEC, IEX, HILIC) and capillary electrophoresis (CGE, CE-SDS) for characterization of mRNA LNPs and protein biologics. Proven contributor to CMC strategies, regulatory submissions, and technology transfers. Recognized for cross-functional collaboration, mentoring, and hands-on operation of a broad range of analytical platforms.
Overview
21
21
years of professional experience
Work History
Senior Scientist, Analytical R&D
GlaxoSmithKline Vaccines
Cambridge, MA
12.2020 - Current
- Designed, established, and qualified chromatography and capillary electrophoresis methods for mRNA drug substance (DS) and drug product (DP) in compliance with ICH Q2(R2).
- Supported non-GMP testing, in-process characterization, forced degradation, and stability studies (accelerated, in-use, and long-term).
- Established a high-throughput mRNA LNP integrity assay using Sciex PA800, Femto Pulse, and Fragment Analyzer, improving reproducibility across platforms.
- Executed mRNA LNP formulation characterization on Vanquish Prime SQ to optimize lipid nanoparticle composition.
- Established a residual p-mercaptoethanol assay for HPV vaccine intermediates and purified bulk; led successful method transfer to a CDMO.
- Developed an RP-UPLC method for HPV VLPs to improve L1 expression monitoring and purity assessment.
- Provided analytical support for the RSV PreF (AREXVY) program using SEC-UPLC, RP-HPLC/UPLC, IEX, HILIC, and CE-SDS, ensuring data integrity.
- Authored and reviewed SOPs, qualification packages, and study reports; mentored junior scientists and strengthened team analytical capability.
Scientist, Formulation Development
Emergent BioSolutions
Gaithersburg, MD
06.2013 - 11.2020
- Executed feasibility and stability studies for protein vaccine formulations; quantified adjuvant content using IP-RP-UPLC and characterized adjuvant–protein interactions.
- Evaluated chemical modification effects on vaccine immunogenicity; performed elemental (ICP-OES) and amino acid analyses to support stability assessments.
- Supported universal influenza vaccine programs using SEC-based analytical methods.
- Authored protocols, SOPs, and regulatory documentation; trained and mentored junior team members.
Associate Scientist (Contract)
Emergent BioSolutions
Gaithersburg, MD
02.2012 - 02.2013
- Optimized purification processes for anthrax vaccine.
- Performed resin screening, binding capacity, and reuse studies using ÄKTA chromatography systems.
- Conducted UF/DF operations utilizing crossflow and TFF systems.
Protein Purification Specialist
Zyngenia Inc.
10.2011 - 01.2012
- Purified multispecific antibodies using Protein A chromatography to support downstream processing activities.
ORISE Fellow – Office of Regulatory Science (CFSAN)
U.S. Food & Drug Administration
College Park, MD
10.2007 - 09.2011
- Built scale-down purification models for Clostridium botulinum neurotoxins.
- Qualified high-throughput detection assays (ELISA, ECL) and conducted BSL-1/2 microbiological testing under Select Agent regulations.
Research & Teaching Assistant
University of Massachusetts Dartmouth
08.2005 - 06.2007
- Investigated protein structural differences using ATR-FTIR spectroscopy.
- Supported laboratory instruction in biochemistry and analytical chemistry.
Education
M.S. - Biochemistry
University of Massachusetts Dartmouth
M.S. - Chemistry
University of Delhi
B.S. - Chemistry
University of Delhi
Skills
- Analytical Method Design & Qualification (ICH Q2(R2))
- MRNA LNP & Protein Biologics Characterization
- Chromatography: RP-HPLC/UPLC, SEC, IEX, HILIC
- Capillary Electrophoresis: CGE, CE-SDS
- Instrument Operation, Troubleshooting & System Suitability
- CMC Support, Regulatory Submissions & Tech Transfer
- Stability, Forced Degradation & In-Process Studies
- Cross-Functional Leadership & Mentoring
- Training and mentoring
- Safety processes and procedures
Publications
- Sachdeva, A. et al. (2010). Detection of Clostridium botulinum in low-acid canned food systems. Applied & Environmental Microbiology.
- Sachdeva, A., & Cai, S. (2009). Protein structural analysis via ATR-FTIR. Applied Spectroscopy.
Timeline
Senior Scientist, Analytical R&D
GlaxoSmithKline Vaccines
12.2020 - Current
Scientist, Formulation Development
Emergent BioSolutions
06.2013 - 11.2020
Associate Scientist (Contract)
Emergent BioSolutions
02.2012 - 02.2013
Protein Purification Specialist
Zyngenia Inc.
10.2011 - 01.2012
ORISE Fellow – Office of Regulatory Science (CFSAN)
U.S. Food & Drug Administration
10.2007 - 09.2011
Research & Teaching Assistant
University of Massachusetts Dartmouth
08.2005 - 06.2007
B.S. - Chemistry
University of Delhi
M.S. - Biochemistry
University of Massachusetts Dartmouth
M.S. - Chemistry
University of Delhi