Kristopher Whalen
Somerset,NJ
Summary
Participating in a team to deliver next-generation pharmaceuticals for the public.
Overview
6
6
years of professional experience
Work History
Scientist
Merck
02.2022 - Current
- Works in Bioanalytical Research and Development, MRL Division
- Collaborates in cross-functional teams to deliver analytical support across stages of development
- Creates and executes method development for novel therapeutics, primarily ADCs
- Responds to international queries and provides support on technical documents
- Extensive instrumentation use
Analyst
Labcorp Drug Development
09.2021 - 02.2022
- Analyst role in GLP lab to support pharmaceutical development via wet chemistry and computer-assisted analysis
- Worked closely with dosing departments to ensure proper test article formulation and delivered dosage
- Performed stability, matrix stability, homogeneity, and dose confirmation analysis
- Created/wrote analytical methods and protocols per test article or specific study requirements
- Designed methods for HPLC-UV or UV Spectrophotometer analysis
- Formulated stock solutions, calibration standards, QC checks, reagents, etc.
- Peer review of data; ensured accurate results are produced following GLP standards
- Communicates results, potential issues, OOS investigations, and other relevant information to Study Directors and Coordinators to ensure timely and cohesive reporting of results
Forensic Extraction Technologist
LabCorp
01.2018 - 02.2022
- Performed numerous extraction procedures to determine specific analyte concentration per SOPs
- Liquid/liquid, supported-liquid, solid-phase extraction techniques
- Maintained legal chain of custody and HIPAA compliance for highly sensitive testing
- Worked quickly and with high fidelity; created own workflow and prioritization schedule during unsupervised hours
- Achieved lowest batch failure rate; exceeded 50% greater-than-average sample clearance
- Created daily and bulk reagents and submitted for validation
- Ran controls and calibrators for validation in conjunction with QA/QC
- Validation and calibration of new/existing instruments
Forensic Mass Spectroscopy
LabCorp
04.2020 - 06.2020
- Completed training for HPLC/MS-MS and GC/MS operation and result interpretation during daily workload
- Analyzed data according to SOPs to ensure batch and sample acceptability
Molecular Diagnostics Supplement
LabCorp
03.2020 - 03.2020
- Provided intermittent, as needed support for various testing departments during LabCorp's rapid COVID-19 testing response
Forensic Confirmation Aliquot Supplement
LabCorp
12.2018 - 05.2019
- Produced batches from LIMS, gathered, and organized samples from various locations with specific storage requirements to expedite laboratory turnaround time
Education
Master of Science - Cell Science And Microbiology
University of Florida
Gainesville, FL05.2021
Bachelor of Science - Biology
The Pennsylvania State University
State College, PA08.2017
Skills
- Wet chemistry/analyte extraction
- HPLC/MS, HPLC/UV, GC/MS, UV-Spec
- Matrix and formulation stability
- HIPAA and other federal compliance; GLP, SAMHSA regulations
- MS Office, LIMS, Analyst, Chromeleon, and associated computer systems
- Leadership and collaboration
- Problem-solving
- Analytical Writing
- Analytical method authoring, review
Timeline
Scientist
Merck
02.2022 - Current
Analyst
Labcorp Drug Development
09.2021 - 02.2022
Forensic Mass Spectroscopy
LabCorp
04.2020 - 06.2020
Molecular Diagnostics Supplement
LabCorp
03.2020 - 03.2020
Forensic Confirmation Aliquot Supplement
LabCorp
12.2018 - 05.2019
Forensic Extraction Technologist
LabCorp
01.2018 - 02.2022
Master of Science - Cell Science And Microbiology
University of Florida
Bachelor of Science - Biology
The Pennsylvania State University