Rachel Kimble
Phoenixville,PA
Summary
Accomplished scientist with extensive experience in the pharmaceutical industry, specializing in analytical development. Demonstrated ability to design and execute complex analytical methods while ensuring compliance with GMP standards. Authored numerous technical documents and presented findings both internally and externally, contributing to the advancement of therapeutic protein development.
Overview
13
13
years of professional experience
Work History
SENIOR RESEARCH ASSOCIATE
TEVA PHARMACEUTICALS
WEST CHESTER, PA
07.2021 - Current
- Designed, executed, and interpreted forced degradation and characterization studies as FDS SME within Analytical Development team. Analyzed samples and optimized methods for SE-HPLC, CE-SDS, icIEF, IEX-HPLC, HIC-HPLC, peptide mapping, intact/reduced/subunit analysis, protein concentration, sub-visible particle analysis, and DLS for traditional mAbs, bispecifics, and fusion proteins. Authored guidance documents, protocols, technical reports, and regulatory responses to support projects from pre-IND to BLA.
- 2026 CE Pharm presenter - HHL Isolation: An Innovative Solution to Determining the Biological Function of Product Variants
- 2025 Teva R&D Summit presenter - Unique Impact of Chemically and Photo-induced Tryptophan Oxidation on Biological Function
- 2025 CASSS poster - The Impact of Chemically & Photo-induced Oxidation on Biological Function of an IgG4 Monoclonal Antibody
- 2024 Analytical Development Project Representative training completed
- Led initiatives for Teva Learn Grow Inspire, developing and presenting webinars on scientific storytelling to enhance team communication and knowledge sharing.
- Presented on Anion Exchange Chromatography at 2023 Teva R&D Summit, contributing insights into improved characterization techniques.
SCIENTIST 3, SEPARATIONS GROUP LEADER
EUROFINS PSS
MALVERN, PA
05.2019 - 07.2021
- In-sourced employee in a pharmaceutical company's Analytical Development team. Contributed to investigations, developed novel HPLC and CGE methods, and worked to qualify and validate analytical methods. Routinely used icIEF, CGE-LIF, SE-HPLC, IEX-HPLC, ProA-HPLC, SoloVPE, and HPLC-ELSD to assess bispecific mAbs and CAR-T products. Managed a large team of in-sourced employees.
- Established community service employee resource group to enhance employee engagement.
- Operated laboratory instruments for sample preparation, analysis, and data review.
SCIENTIST, PHARMACOKINETICS TEAM LEAD
ABSORPTION SYSTEMS
EXTON, PA
10.2015 - 04.2019
- Developed and optimized HPLC/UPLC, mass spectrometry, and sample preparation methods, enhancing analytical capabilities for pharmacokinetic studies. Experience developing both reversed-phase and normal-phase chromatography methods. Executed sample preparation and extraction, UPLC-MS/MS analysis, data review, documentation, and report preparation to ensure accuracy and compliance in pharmacokinetic research. Managed the delegation of pharmacokinetic studies while mentoring and training junior staff members. Supported in-vitro and radioactive projects.
SCIENTIST 1
DRUGSCAN
HORSHAM, PA
04.2014 - 10.2015
- Prepared test articles using extraction techniques including protein precipitation, liquid-liquid, solid-phase extraction, and automation equipment such as automated manifold and TECAN to support analytical processes. Analysis completed using HPLC/UPLC coupled with triple quadrupole mass spectrometry. Reviewed and interpreted MS/MS and LDTD data to ensure accuracy and reliability of results. Maintained and repaired instrumentation, prepared shared laboratory reagents, and trained junior staff members.
- Reviewed chain of custody documentation for incoming samples.
Education
BACHELOR OF SCIENCE - PROFESSIONAL STUDIES, BIOLOGY, HEALTH SCIENCE
WEST CHESTER UNIVERSITY OF PENNSYLVANIA
West Chester, PASkills
- Analytical method development, qualification, & validation
- Design of complex studies & interpretation of results: structure-function, forced degradation, pharmacokinetic, impurities, and more
- HPLC & UPLC paired with MS, DAD, FLD, ELSD, and fraction collection Non-LC-based techniques: icIEF, CGE, CZE, Fixed & Variable Pathlength UV-Vis, DLS, and sub-visible particless
- GMP, & CLIA-Certified, & R&D laboratories
- Experience with Empower, 32-Karat, iCE CFR, Bio Pharma Finder, Freestyle, Xcaliber, Symyx/BIOVIA ELN, IDBS Polar ELN
- Project management
ADDITIONAL EXPERIENCE
Full- and part-time positions providing patient care from 2010-2021. Work focused on providing quadriplegic care in-home and at care facilities. Responsibilities included medication administration, catheter care, physical/occupational therapy and range-of-motion exercise, and assistance with activities of daily living. Additional responsibilities included staff scheduling and on-call coverage for a variety of patients, including hospice and dementia care.
Timeline
SENIOR RESEARCH ASSOCIATE
TEVA PHARMACEUTICALS
07.2021 - Current
SCIENTIST 3, SEPARATIONS GROUP LEADER
EUROFINS PSS
05.2019 - 07.2021
SCIENTIST, PHARMACOKINETICS TEAM LEAD
ABSORPTION SYSTEMS
10.2015 - 04.2019
SCIENTIST 1
DRUGSCAN
04.2014 - 10.2015
BACHELOR OF SCIENCE - PROFESSIONAL STUDIES, BIOLOGY, HEALTH SCIENCE
WEST CHESTER UNIVERSITY OF PENNSYLVANIA