Jeremy Johnston
Durham,NC
Summary
Accomplished Biologics CMC Leader with 20+ years of cross-functional experience bridging major pharmaceutical sponsors and premier fee-for-service CRO/CDMO organizations. Proven track record establishing and scaling multi-site biologics and cell/gene therapy (CGT) capabilities, driving commercial portfolio growth, and managing end-to-end program lifecycles from IND-enabling through BLA filings. Recognized SME in analytical development, drug product/formulation strategy, tech transfer, and regulatory submissions. Adept at leveraging deep technical credibility to author proposals and lead client engagements across North American biotech corridors.
Overview
24
24
years of professional experience
Work History
Scientific Strategy Advisor, Cell & Gene Therapy Business Development
Eurofins Lancaster Laboratories, LLC.
Lancaster, PA
01.2023 - Current
- Provide analytical governance and technical leadership for the build-out of platform analytical methods for cell and gene therapy (CGT) programs, ensuring technical capabilities meet stringent global regulatory standards.
- Worked with Lancaster site leadership to establish a NGS laboratory to enable testing for adventitious agents, genome identity, integration site analysis and impurity characterization for cell and gene therapy products. Purchased illumina NextSeq2000, MiSeqDx instrumentation as well as ONT Gridion systems. Collaborated with clinical IT group for pipeline development and cloud data storage with the goal to establish GMP NGS testing offering.
- Championing and leading new business development initiatives (Mass Photometry, Flow Cytometry and NGS) both internally and externally with strategic partners and different business units.
- Oversee laboratory infrastructure and equipment readiness, ensuring on-site technical investments enable advanced characterization (purity, identity, potency) and stability testing for large molecule programs.
Director, Analytical Development & Formulation
Asklepios BioPharmaceutical (AskBio)
RTP, NC
11.2019 - 12.2022
- Built and scaled a 25-person multidisciplinary analytical development group (6 direct reports) from the ground up, aligning organizational capabilities with long-term portfolio growth strategy and investment priorities
- Acted as a core CMC leader and strategic owner for a high-value portfolio of AAV programs; managed lifecycle accountability from pIND through clinical supply, ensuring technical milestones met commercial ROI thresholds.
- Designed and launched a state-of-the-art formulation lab, enhancing internal characterization capabilities and supporting long-term portfolio growth through differentiated analytical depth.
- Directed global technology transfer initiatives across international CDMO sites, ensuring analytical release and stability methods were successfully validated for cross-border clinical supply. Assisted them with interpretation of global regulations and work to appropriately apply, implement and communicate established and draft guidance. Coached them to understand CMC expectations and identify regulatory opportunities and risks.
- Lead phase-appropriate analytical strategies for Phase I/II programs, serving as the strategic CMC owner to define reference standard qualification and stability program setup.
Principal Scientist, Analytical Process Development
Fujifilm Diosynth Biotechnologies
RTP, NC
03.2015 - 11.2019
- Accountable for method qualification, validation strategy, specifications, and sampling plans supporting GMP manufacturing supporting mammalian and microbial production systems.
- Lead a group of 5 direct reports (senior scientists and scientists) in the analytical development group. My group had expertise in both large molecule (monoclonal antibodies, vaccines, fusion proteins) analytical method and formulation development, testing as well as validation, manufacturing and Quality Assurance.
- Worked on drug substance manufacturing readiness by authoring supplemental sampling plans and item specifications. Author and review test methods, investigations and batch records. Work with QC department and CMC teams to provide troubleshooting of assay non-conformances and out of trend results.
Senior Manager, Biopharmaceutical Development
AAI Pharma
Wilmington, NC
04.2013 - 03.2015
- Managed a group of 5 senior scientists and scientists in the biopharmaceutical development group. My group had expertise in large molecule analytical method development, testing as well as validation and tech transfer. Performed review of testing results, author reports, and communicate results with clients.
- Served as an analytical project director for multiple development and stability projects in a matrix environment. In this role I provided leadership to cross-functional teams during validation and tech transfer and establish stability schedules and timelines. Performed LIRs for non-conformances and trending of stability data.
Subject Matter Expert, Third Party Manufacturing
Bristol Myers Squibb
Syracuse, NY
04.2012 - 03.2013
- Managed global technology transfers, process validation, and quality audits across CMO/CRO partner networks to guarantee sterile manufacturing readiness and GMP compliance in support of our monoclonal antibody programs.
- Worked with CMO analytical groups to troubleshoot and resolve issues throughout stability and release testing processes.
- Participated in third party site quality audits; including review of batch records, analytical test methods, equipment maintenance and training programs. I assisted the CROs/CMOs to work toward process and procedure improvements that drive system compliance and effectiveness.
Senior Scientist, Biophysical Characterization
Catalent Pharma Solutions
RTP, NC
04.2010 - 03.2012
- I performed a detailed chemical analysis of several recombinant proteins and small molecules in a CMO setting. Assays included Microscopic Particle Count, RP-HPLC, LC/MS/MS, circular dichroism, carbohydrate characterization and SEC-MALS
- Supervised a group of 4 scientists in the analytical characterization and GMP/GLP testing laboratory. Served as project director for long term stability studies as well as characterization projects for a number of APIs (proteins, polymers, parenterals)
Senior Scientist, Analytical Development
AlphaVax, Inc.
RTP, NC
05.2008 - 03.2010
- Involved in scale up of vaccine phase I and II clinical material. I performed a detailed structural characterization of vaccine vectors by Chip Q-TOF/MS, qPCR, Bioassay and ELISA. Developed a tryptic peptide map to identify carbohydrates on cell surface proteins as well as sequence host cell proteins from SDS-PAGE gels
- Developed a novel viral infectivity bioassay by combining a cell-based assay approach with mass spectrometry. The assay allowed for quantitation of expressed genes of interest in a Vero cell as an orthogonal approach to ELISA development.
Research Scientist, Bioanalytical Sciences
Bristol Myers Squibb
Pennington, NJ
11.2002 - 05.2008
- Authored and reviewed key Module 3 (3.2.S.2) characterization sections for successful BLA filings for landmark biologics (abatacept, belatacept, ipilimumab).
- Developed and optimized peptide map methods to identify and monitor Critical Quality Attributes (CQAs) of drug substance and drug product. Identified peptide sequences and identified post-translational modifications by LC/MS/MS and N-terminal sequencing
- Trained as an Empower client-server administrator at Waters Corporation. I used my experience with Empower to write new processing and report methods utilizing custom fields to improve data reporting and make review of data more efficient.
Education
BACHELOR OF SCIENCE - Zoology
Michigan State University
East Lansing, MIMASTER OF SCIENCE - Molecular Biology
Wayne State University
Detroit, MISkills
- Strategic Business Development
- Cross-Functional Program Management
- SOW & Proposal Development
- Site & Facility Operations
- LC/MS Characterization of Biologics
- CDMO/CRO Governance
- AAV, Protein & mRNA Modalities
- Risk Mitigation & Compliance
- Executive Leadership Partnership
- Global Tech Transfer Oversight
- LC-MS/MS
- Excel
- Power BI
- CRM
- HPLC
- Copilot
- SoftMax Pro
- Empower 3
- LabWare LIMS
- TrackWise (Deviations/CAPA)
- JMP/Minitab (DOE & Statistical Analysis)
Timeline
Scientific Strategy Advisor, Cell & Gene Therapy Business Development
Eurofins Lancaster Laboratories, LLC.
01.2023 - Current
Director, Analytical Development & Formulation
Asklepios BioPharmaceutical (AskBio)
11.2019 - 12.2022
Principal Scientist, Analytical Process Development
Fujifilm Diosynth Biotechnologies
03.2015 - 11.2019
Senior Manager, Biopharmaceutical Development
AAI Pharma
04.2013 - 03.2015
Subject Matter Expert, Third Party Manufacturing
Bristol Myers Squibb
04.2012 - 03.2013
Senior Scientist, Biophysical Characterization
Catalent Pharma Solutions
04.2010 - 03.2012
Senior Scientist, Analytical Development
AlphaVax, Inc.
05.2008 - 03.2010
Research Scientist, Bioanalytical Sciences
Bristol Myers Squibb
11.2002 - 05.2008
MASTER OF SCIENCE - Molecular Biology
Wayne State University
BACHELOR OF SCIENCE - Zoology
Michigan State University