About Me.
My consulting practice is built on deep, hands-on in GMP quality and QMS design, from commercial pharma to cell and gene therapy startups. I work as a subject matter expert with one goal: remove the bottlenecks that slow quality processes down, so quality supports the business instead of stalling it.
FOCUS
Emerging biotech companies in Philadelphia
"Cellicon Valley" where I am based, as well as
consulting globally and across the U.S.
EXPERIENCE
QMS builds, remediation, and audit programs across big pharma, academic cell therapy manufacturing, and venture-backed biotech.
RESULTS
Measurable improvements in quality performance, compliance, and efficiency.
My chemistry training taught me to be analytical and organized. I hold a Master's degree in Organic Chemistry. I started in the QC lab and worked my way through GMP commercial manufacturing roles before moving into academia to learn cell and gene therapy, where I was part of the Penn CAR-T program that became Kymriah. I know Quality Management Systems deeply, and I'm at my best turning problems into improvement projects. Who doesn't want things to be simple and efficient?
For my full background, visit my LinkedIn profile.
Key Competencies/Skills:
QMS Implementation
Developing/delivering Training Program/Content
Change Management Champion
Internal/External Auditing
3rd Party Management/CMO oversight
Strategic and Tactical Planning
Organizational and Negotiating Skills
QA Unit development – Building/optimizing teams, hiring staff
Manage Quality Remediation Projects
My Areas of Expertise
CELL AND GENE THERAPY
Expertise: GMP Mfg, Sterile Mfg, Quality Operations, QMS, Hiring/Onboarding, GxP Vendor Auditing, Change Mgt, Quality Planning, Vendor Mgt, Training, Risk Mgt, Batch Record Review
PHARMA/COMMERCIAL MFG
Expertise: QA Operations, Stability Program, GxP Training, Consent Decree, Warning Letter, 483 Remediation, Cleaning Validation, CMC, Analyst Certification Program
QC & LAB OPERATIONS
Expertise: Good Laboratory Practices, Housekeeping, Product & In-Process Testing, Batch Record Review, Commercial GMP Manufacture, FDA Audit, CSV, Method Validation/ Verification, Analytical Method Transfer, Equipment PM/CM
My career in cell and gene therapy has given me a front-row seat to some of the most groundbreaking advances in modern medicine. At Penn’s Center for Cellular Immunotherapies, I supported the CAR-T program that ultimately became Kymriah - the first cell therapy approved in the U.S. - by embedding GMP and QA strategies into an environment where research was moving faster than the systems around it.
At Gyroscope Therapeutics, I was given a blank canvas to build the Quality organization. I developed the QMS from the ground up, redesigned vendor management and audit programs, and streamlined critical processes so they were both compliant and practical.
When Novartis acquired the company, I guided quality activities through the inevitable growing pains of integration, shifting priorities, pressing timelines, and organizational change. These experiences sharpened my skills in strategic planning, change management, and cross-functional collaboration, and reinforced my belief that Quality can empower innovation instead of slowing it down.
In the PHARMA sector, I built a strong foundation in commercial GMP environments by supporting and improving core QA processes. On assignment for GSK, I managed a portion of their GMP training program, requiring strategic vision and international travel to deliver critical QMS topics. I developed a global training program, executed internal audit plans, and championed change management across multiple global sites.
Supporting a project at McNeil's Johnson & Johnson, I engaged in FDA 483 remediation efforts and directed large-scale change management projects. At Cordis, also with Johnson & Johnson, I served as a global expert in Cleaning Validation, ensuring compliance across multiple international sites. My problem-solving skills contributed to the development of a document archival system, which received positive feedback from senior leadership. As a Training Consultant at the San German site in Puerto Rico, I developed and delivered a scientific training program in response to an FDA 483, ensuring certification and competency among QC Lab staff. I really enjoyed teaching younger laboratory staff valuable tips of the trade that come only with experience!
The official start of my career was as a self-proclaimed lab rat (and oh, how I loved it!) — pulling graveyard shifts in Eli Lilly’s QC/GMP lab, running in-process and final product tests for small molecules. My survival strategy? Riding up and down the manufacturing floor on the lab tech “golf cart” to stay awake between samples! That killer night shift propelled me into graduate school, and when I returned to Lilly as a Project Chemist, I was given carte blanche to do what I love most: find smarter, faster, simpler ways to work. I redesigned procedures that cut down deviations, created troubleshooting guides that actually worked, and aligned testing with international standards.
One of my favorite wins was eliminating redundant chromatographic testing, an FDA-reportable change that reduced cycle time from five days to three and saved significant costs, which was then replicated multiple times across the lab for other groups and operations. I also drove countless process maps to spot and eliminate waste. Even back then, I was happiest when I was solving problems, streamlining work, and making quality systems more efficient (with or without the golf cart).
