Lolita Lynch
Downingtown
Summary
Highly motivated professional with extensive experience in CGMP Quality Operations of testing gene/cell therapies, biopharmaceuticals, pharmaceuticals, and medical devices. Proud to foster true change in an organization through servant leadership and driving positive growth within teams and company culture. Consistently recognized for excellent performance, initiative, and continuous learning. Effective oral and written communication across all departments and organized levels. Experienced in implementing quality and improvement initiatives and writing technical documents. Highly adaptable and comfortable working in a dynamic, results-driven environment either as a collaborative team member or independently to complete objectives.
Overview
14
14
years of professional experience
Work History
Global Project Manager, Quality Control-Contract Position
JOHNSON & JOHNSON
08.2023 - 02.2025
- Managed transition of a paper-based process into eLIMS for all critical reagents used in analytical and microbiological testing of CAR-T product.
- Created mapping of critical reagent process from end-to-end to include receipt of material in-house, quarantine, material sampling, receipt into QC laboratories, reagent preparation and storage, testing, data collection and analysis, COA generation, and release of material into inventory.
- Supported and coordinated activities between Global and local teams regarding interfacing current instrumentation (qPCR, flow cytometry, ELISA, endotoxin, and sterility testing) to eLIMS to ensure data generated parses correctly into eLIMS.
- Supported local team with impact assessments for enhancements to current electronic lab methods to ensure revisions are within compliance.
Associate Director, Quality Control
OCUGEN, INC.
Malvern
08.2022 - 08.2023
- Constructed a CGMP Quality Control laboratory to support analytical and microbiological testing for a Phase III autologous cell therapy product, which include plate based analytical methods, qPCR, cell count and viability, histology, endotoxin, sterility, mycoplasma, and Environmental Monitoring.
- Provided strategic direction and expertise for equipment qualification, critical reagent qualification, stability testing, and phase appropriate method validation.
- Created an Environmental Monitoring program to include air, surface, and non-viable particulate monitoring for Environmental Monitoring Performance Qualification, disinfection efficacy studies, routine and aseptic processing collection, gowning qualification, and media fill simulation.
- Created a raw material program for material inspection, quarantine, QC sampling and testing, retain and disposition of incoming raw materials, which include identification of critical raw materials and appropriate raw material qualifications.
- Provided strategic direction for QC technology transfer of analytical methods developed by the Analytical Development team into the QC laboratory.
- Served as the Subject Matter Expert in support of Quality audits at assigned contract testing laboratories.
- Created QC laboratory procedures which include routine equipment preventative maintenance, sample management, decontamination and biohazard removal, chemical storage, and raw material testing (pH, osmolality, endotoxin, performance testing, microbial growth promotion, identity testing using ELISA, etc.).
- Created procedures to support investigations of Out-of-Specification and Out-of-Trend results and other testing discrepancies.
- Developed solutions to complex Quality issues which could potentially impact cell therapy manufacturing and testing to ensure patient safety and compliance with CGMP regulations.
- Developed a QC training program to support testing performance expectations for analytical, Environmental Monitoring, and safety testing.
- Constructed department budget and submission of budgetary corrections to long term production strategies.
- Cross-functional collaboration with Regulatory Affairs, Clinical Operations, Quality Assurance, Manufacturing, Operations, Supply Chain Management, Facilities and IT to ensure implementation of procedures is within compliance and supports corporate goals.
- Responsible for the recruitment, onboarding, development, management, and retention of employees.
Manager, Global QC
IOVANCE BIOTHERAPEUTICS
Philadelphia
01.2022 - 07.2022
- Managed all stability studies for all Tumor Infiltrating Lymphocyte (TIL) Drug Product and excipients including development of stability studies adhering to ICH and USP guidelines, engineering runs, comparability studies between CDMOs, and PPQs.
- Harmonized analytical test methods between internal and external testing sites to confirm consistency between execution of analytical testing.
- Supported analytical test method validations to align with ICH guidelines including protocol and report generation.
- Supported review of stability related sections for proposed BLA submission.
Analytical Project Lead
GLAXOSMITHKLINE
Upper Merion
10.2020 - 12.2021
- Managed analytical technology transfers from mid to late-stage Biopharmaceutical Development into CGMP commercial testing laboratories.
- Oversight provided to external contract testing capability to support biological drug pipeline.
- Managed analytical contracts and relationships with external contract testing laboratories.
- Authored product analytical specifications, analytical methods, method transfer/qualification/validation protocols and reports to ensure alignment with phase appropriate project requirements.
- Authored and review analytical sections for regulatory submissions to support product development progression.
QC Supervisor
Castle Creek Biosciences (formerly Fibrocell Science)
Exton
03.2017 - 09.2020
- Lead day-to-day Analytical and Microbiology operations for in-process, Drug Substance, and Drug Product for Gene Therapy operations to ensure execution of testing.
- Drove projects for Process Development and Proof of Concept studies, including technology transfers for current indications to ensure capability of analytical testing in-house through further development, qualification, and validation of test methods.
- Developed and qualified analytical test methods to support potency testing requirements per adhere to the Food and Drug Administration’s Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
- Worked to ensure compliance with SOPs and industry regulations, such as 21 CFR Parts 210 and 211. Supported regulatory filings and inquiries from authorities.
- Responsible for budget planning, including annual capital expenses, headcount, and space planning (laboratory construction/expansion).
- Responsible for performance management, personnel development, hiring and onboarding of new staff, and driving team metrics towards corporate goals.
Analytical Lab Manager / QA Specialist
HAVPAK, INC.
Malvern
05.2016 - 03.2017
- Established the Analytical lab: performed all aspects of lab design including procurement of equipment, reagents, and consumables; validated all lab equipment; authored all equipment SOPs and test methods.
Lead Quality Assurance Specialist
FIBROCELL SCIENCE
Exton
07.2014 - 05.2016
- Reviewed Manufacturing Batch Record documentation for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of autologous cell therapy in-process, Bulk-Drug Substance, and Final Drug Product.
- Managed approval of COAs for in-process material, final product, and sterility samples.
- Interpreted data, offered Subject Matter Expertise and recommendations for business decisions.
- Assisted in annual product review.
- Reviewed QC testing data against established specifications.
- Quarantined and authorized final disposition of raw materials for Manufacturing and QC.
Lead Analyst, QC
FIBROCELL SCIENCE
Exton
06.2011 - 07.2014
- Supervised daily activities for 7 QC Associates in the Analytical and Microbiological laboratories.
- Managed and reviewed raw data, including analytical testing, raw material, Environmental Monitoring, and Growth Promotion to ensure accuracy, strength, identity, safety, purity and quality of autologous cell therapy in-process, Bulk-Drug Substance, and Final Drug Product.
- Executed, resolved, and authored general technical reports for investigational testing, revealing possible root causes for out-of-specification results.
- Supported product manufacturing by employing manual and automated analytical equipment for cell count and cell viability, cell identity, endotoxin testing, collagen content determination, Environmental Monitoring and sterility testing.
- Authored, reviewed and approved SOPs, Analytical Test Methods, Raw Material specifications, protocols and technical reports.
- Managed raw material program, which included working with contract laboratories to ensure proper implementation of testing and receipt of testing data.
Education
Bachelor of Science - Microbiology
The Ohio State University
Columbus, OH03-2008
Skills
- Project management
- Regulatory compliance
- Data analysis
- Quality assurance
- Technical writing
Timeline
Global Project Manager, Quality Control-Contract Position
JOHNSON & JOHNSON
08.2023 - 02.2025
Associate Director, Quality Control
OCUGEN, INC.
08.2022 - 08.2023
Manager, Global QC
IOVANCE BIOTHERAPEUTICS
01.2022 - 07.2022
Analytical Project Lead
GLAXOSMITHKLINE
10.2020 - 12.2021
QC Supervisor
Castle Creek Biosciences (formerly Fibrocell Science)
03.2017 - 09.2020
Analytical Lab Manager / QA Specialist
HAVPAK, INC.
05.2016 - 03.2017
Lead Quality Assurance Specialist
FIBROCELL SCIENCE
07.2014 - 05.2016
Lead Analyst, QC
FIBROCELL SCIENCE
06.2011 - 07.2014
Bachelor of Science - Microbiology
The Ohio State University
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