In the biopharmaceutical industry, the transition from the bench to the facility floor is rarely
a straight line. I act as the Missing Link in Process Evolution, bridging the gap between
process development and manufacturing. I focus on the technical and scientific aspects of
production to solve problems, optimize processes, and support the technology transfer and
scaling-up of drug candidates.
My expertise is defined by Rapid Adaptation and Ambiguity Tolerance. I thrive in environments
where the path forward is unclear, taking on tasks that are urgent, high-visibility, or
technically complex, and driving them to completion with enthusiasm.
Leveraging a unique blend of scientific curiosity and engineering discipline to deliver results.
Bridging R&D and cGMP manufacturing to deliver robust, scalable bioprocesses. Support for cell and gene therapies, vaccines, and biologics.
Identifying subtle deviations and driving continuous improvement to safeguard product streams. Synthesizing batch data to ensure process consistency.
Generating effective templates, calculations, and SOPs that improve data integrity and usability. Designing the workflows that connect process and analytical data.
Leading investigations for critical process deviations. Conducting Root Cause Analysis (RCA) and authoring CAPAs to resolve recurring issues in yield and contamination.
Insight Global (Client: Merck) | Rahway, NJ | Aug 2024 – Sep 2025
Authored and configured GMP-compliant Process and Knowledge Management (PKM) recipes,
translating complex tech transfer protocols into precise digital workflows to support system
rollout across global sites. Developed and standardized GMP documentation and workflows for the
PKM software, ensuring seamless user adoption and data integrity network-wide.
Oxford Global Resources (Client: Immunovant) | New York, NY | Mar 2024 – Aug
2024
Reviewed and verified manufacturing data from multiple CMO partners, maintaining technical
oversight and alignment with established protocols for clinical-stage assets. Engineered process
trend charts leveraging manufacturing run data to verify process control, enabling early
detection and mitigation of potential deviations.
Delta Project Management / Verista (Client: Novavax) | Gaithersburg, MD | 2020 –
2023
Led the cross-site Continued Process Verification (CPV) program, synthesizing batch data from 3+
global CMOs to ensure process consistency and product quality during a large-scale vaccine
program. Initiated and managed upstream process monitoring, identifying subtle process
deviations in cell growth and proactively driving corrective actions that safeguarded
multimillion-dollar product streams. Served as the lead technical investigator for critical
process deviations, conducting root cause analysis (RCA) and authoring CAPAs that resolved
recurring issues with process yield and contamination. Authored and executed cross-site process
comparability protocols and reports, generating key data to support regulatory filings and
operational change controls.
Paragon Bioservices / Catalent Pharma Solutions | Baltimore, MD | 2016 –
2020
Directed the end-to-end technology transfer of 5+ novel cell culture, fermentation, and viral
production processes from client labs into a commercial cGMP facility. Authored and reviewed
cornerstone process documentation (PFDs, MBRs, SOPs), and spearheaded process improvements that
streamlined documentation workflows and reduced generation time. Served as the central MSAT
point of contact for multiple clients, aligning project requirements with CMO operational
capabilities to maintain aggressive production timelines. Provided SME support during the
commissioning, procurement, and startup of Paragon’s first commercial manufacturing facility.
Contact me to discuss how I can support your bioprocess needs.