KATE HICKS
Spring city
Summary
A highly motivated and dedicated science professional with over 18 years of Regulated Vaccines, GLP/GCP, and industry experience. Strategic and goal-oriented team collaborator with broad knowledge across the Vaccine Portfolio. Focus on streamlining processes and identifying efficiencies to achieve deliverables.
Overview
2026
2026
years of professional experience
Work History
Principal Scientist
Merck Sharp & Dohme, LLC
2022 - Current
- Pipeline Strategy: Provide key strategic and scientific direction for lab assay transfers, particularly for molecular assays. Led team discussions and help drive progress towards assay validation and Regulatory submissions.
- Track vaccine early development space to identify potential future outsourcing needs.
- Survey the landscape to increase the options in CRO piloting and selection.
- Ensure performance and processes for assay readiness, clinical study completion, data quality and regulatory filings across CRO partners to advance Vaccines pipeline and meet program timelines.
- Directed Leadership: Outsourcing Lead for multiple vaccine programs.
o Process and technical oversight of program objectives in two Chinese labs with high-throughput testing.
o Oversee various program objectives in US-based labs for multiple vaccine assets and candidates including cell-based, serology, and molecular assays.
· Provide organizational and technical oversight as well as critical review of relevant data and scientific reports.
- Scientific Strategy: BioAnalytical Development Lead for Next Generation Vaccine Asset
- o Work cross-functionally across the organization to develop and optimize program strategy including assay development, determine types of data that will drive clinical trials, vendor contracting and oversight.
- o Stakeholder and contributor to Natural History Study Design and collaborative agreements with various University researchers.
- Growth in People Culture: Co-lead of the Outsourcing D&I Committee and Lead Work-Life Balance discussions with the Outsourcing group at large.
Associate Principal Scientist
Merck Sharp & Dohme, LLC
01.2016 - 01.2022
- SME for the Molecular Biology Labs
- Winner of PPDM William Campbell Innovation Award for “A Novel Immuno-Molecular Strategy to support Pneumococcal Conjugate Vaccine Franchise for Indication Expansion” (Dec2021).
- Awarded intern project for Summer 2021 and supervised an undergraduate intern
- Scientific lead in Capital Resource Committee project to modernize the molecular automation capabilities.
- Preclinical Development
Senior Scientist
Merck Sharp & Dohme, LLC
01.2014 - 01.2016
- SME for the Molecular Biology Labs
- Preclinical Development
Group Leader in Molecular Testing
Pharmaceutical Product Development (PPD), Inc.
01.2013 - 01.2014
- Supervised eight direct reports
- Lab manager of high throughput Clinical PCR testing for Phase 2-3 trials
- Formerly Vaccines and Biologics, Merck & Co., Inc. (2007 until Vaccine Clinical Assays were Divested to PPD in January 2009)
Associate Group Leader in Molecular Testing
Pharmaceutical Product Development (PPD), Inc.
01.2010 - 01.2013
- Supervised eight direct reports
- Lab manager of high throughput Clinical PCR testing for Phase 2-3 trials
- Formerly Vaccines and Biologics, Merck & Co., Inc. (2007 until Vaccine Clinical Assays were Divested to PPD in January 2009)
Laboratory Research Technician
Thomas Jefferson University
01.2005 - 01.2007
- Lab techniques: RNA/DNA isolation, Lyophilization techniques, Indirect/direct immunofluorescence, Transformations with EC E. coli, cDNA microarrays, Transfections/nucleofections with liposomes and Amaxa Systems
- Cell culture skills: Maintenance of multiple cell lines, Transgenic cell line assays, Extensive work with mesenchymal stem cells, fibroblasts and keratinocytes
- Animal skills: Breeding/Sexing, Genotyping, Maintenance of multiple transgenic mouse colonies, Isolation of bone marrow and mesenchymal stem cells
- Maintenance of lab: Supply and equipment inventory, Liquid Nitrogen cell repositories, Maintenance of isotope records for safety inspections
- Department of Dermatology and Cutaneous Biology, Gene Therapy Group
Education
Post-Master’s Certificate - Infectious Disease Control
Thomas Jefferson University College of Graduate Studies
Philadelphia, PA01.2010
Master of Science - Microbiology
Thomas Jefferson University College of Graduate Studies
Philadelphia, PA01.2007
Bachelor of Arts - Biology
La Salle University
Philadelphia, PA01.2005
Skills
- Microsoft office (Word, Excel, PowerPoint)
- ABI Design and Analysis
- ABI Primer Express
- Sigma Plot
- Microsoft Office
- FileMaker Pro
- LIMS
- Design Expert
Timeline
Associate Principal Scientist
Merck Sharp & Dohme, LLC
01.2016 - 01.2022
Senior Scientist
Merck Sharp & Dohme, LLC
01.2014 - 01.2016
Group Leader in Molecular Testing
Pharmaceutical Product Development (PPD), Inc.
01.2013 - 01.2014
Associate Group Leader in Molecular Testing
Pharmaceutical Product Development (PPD), Inc.
01.2010 - 01.2013
Laboratory Research Technician
Thomas Jefferson University
01.2005 - 01.2007
Master of Science - Microbiology
Thomas Jefferson University College of Graduate Studies
Bachelor of Arts - Biology
La Salle University
Principal Scientist
Merck Sharp & Dohme, LLC
2022 - Current
Post-Master’s Certificate - Infectious Disease Control
Thomas Jefferson University College of Graduate Studies
Publications
- Flagler K, V Alexeev, EA Pierce, and O Igoucheva. Site-specific gene modification by oligodeoxynucleotides in mouse bone marrow-derived mesenchymal stem cells. Gene Therapy 2008; 0969-7128/08: 1-14.
- Kate L. Hicks, Michael DeHaven, Julia Kelly, Joseph Antonello, Leonard Rubinstein. Digital PCR for the Quantification of a PCR Template to Use in Matrix-Specific qPCR Limits of Detection Determination. Merck Internal Journal: Advances in Merck Drug Substance, Drug Product, and Analytical Development April 2021; Volume 6.
- Kate L. Hicks, Sarah Irey, Julia Kelly, Yuhua Zhang, Joseph Antonello and Leonard J. Rubinstein. Direct PCR for the detection of Streptococcus pneumoniae in Human Cerebrospinal Fluid and Middle Ear Fluid. Merck Internal Journal: Advances in Merck Drug Substance, Drug Product, and Analytical Development. November 2022; Volume 7.
- Gowrisankar Rajam, Kate L. Hicks, Joseph M. Antonello, Yuhua Zhang, Sarah Irey, Julia Kelly, Stephanie Cooper, and Leonard J. Rubinstein. A Novel Immuno-Molecular Strategy for the Detection of Streptococcus pneumoniae Serotypes in Human Cerebrospinal and Middle Ear Fluids. mSphere. Received 13 June 2022, Revised 13 June 2023, Accepted 16 June 2023, Available online 20 June 2023, Version of Record 4 July 2023 A novel immuno-molecular strategy for the detection of Streptococcus pneumoniae serotypes in human cerebrospinal and middle ear fluids - ScienceDirect
- Lead presenter: Site-specific gene modification by oligodeoxynucleotides in mouse bone marrow-derived mesenchymal stem cells. Presented 2007 at Thomas Jefferson University College of Graduate Studies.
- Lead presenter: Digital PCR for the Quantification of Vaccine Drug Products to use in Matrix Specific qPCR Limits of Detection Determination. Presented September 2019 at PPDM Science Day
- Contributor: Direct Real Time PCR from Digested Tissues without Purification. September 2019 at PPDM Science Day
Publications & Posters
Flagler K, V Alexeev, EA Pierce, and O Igoucheva. Site-specific gene modification by oligodeoxynucleotides in mouse bone marrow-derived mesenchymal stem cells. Gene Therapy 2008; 0969-7128/08: 1-14.
Kate L. Hicks, Michael DeHaven, Julia Kelly, Joseph Antonello, Leonard Rubinstein. Digital PCR for the Quantification of a PCR Template to Use in Matrix-Specific qPCR Limits of Detection Determination. Merck Internal Journal: Advances in Merck Drug Substance, Drug Product, and Analytical Development April 2021; Volume 6.
Kate L. Hicks, Sarah Irey, Julia Kelly, Yuhua Zhang, Joseph Antonello and Leonard J. Rubinstein. Direct PCR for the detection of Streptococcus pneumoniae in Human Cerebrospinal Fluid and Middle Ear Fluid. Merck Internal Journal: Advances in Merck Drug Substance, Drug Product, and Analytical Development. November 2022; Volume 7.
Gowrisankar Rajam, Kate L. Hicks, Joseph M. Antonello, Yuhua Zhang, Sarah Irey, Julia Kelly, Stephanie Cooper, and Leonard J. Rubinstein. A Novel Immuno-Molecular Strategy for the Detection of Streptococcus pneumoniae Serotypes in Human Cerebrospinal and Middle Ear Fluids. mSphere. Received 13 June 2022, Revised 13 June 2023, Accepted 16 June 2023, Available online 20 June 2023, Version of Record 4 July 2023 A novel immuno-molecular strategy for the detection of Streptococcus pneumoniae serotypes in human cerebrospinal and middle ear fluids - ScienceDirect
Poster Presentations:
Lead presenter: Site-specific gene modification by oligodeoxynucleotides in mouse bone marrow-derived mesenchymal stem cells. Presented 2007 at Thomas Jefferson University College of Graduate Studies.
Lead presenter: Digital PCR for the Quantification of Vaccine Drug Products to use in Matrix Specific qPCR Limits of Detection Determination. Presented September 2019 at PPDM Science Day
Contributor: Direct Real Time PCR from Digested Tissues without Purification. September 2019 at PPDM Science Day
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