ROLLANDE FRENCH
Philadelphia
Summary
Experienced life sciences and MBA professional with proven track record in pharmaceutical and food quality control, regulatory, compliance and commercial readiness
Overview
16
16
years of professional experience
Work History
Microbiology Team lead
Castle Creek Biosciences
Exton, PA
10.2025 - 03.2026
- Identified and led the EM support of the remediation effort after a DCE which led to major cleanroom renovation.
- Accountable for the development and lifecycle management of the Environmental Monitoring (EM) program, including but not limited to facility and utilities environmental performance qualification, routine monitoring, data trending, EM excursion investigations.
- Responsible for the development and lifecycle management of site specific standard operating procedures related to microbial contamination controls.
- Acted as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological testing.
- Provided input and managed execution of method validation and verification for microbiological testing conducted at the site.
- Lead site QC team while supporting individual development and managing performance.
- Role eliminated due to Company mass layoff due to Facility shutdown.
Project Lead / Senior Consultant
AZZUR GROUP LLC
Philadelphia, PA
05.2023 - 10.2024
- Provided assessment and resolved critical microbiological compliance issues for top pharmaceutical clients
- Participated and supported regulatory agency filings, inspections, and internal audits, as needed
- Served as compliance SME for quality control and assurance
- Prepared and led validation / qualification project master plans, risk and impact assessments, protocols and summary reports and coordinated review and approvals of the documents according to client’s SOPs, FDA and EU regulatory guidelines
- Utilized quality systems to review and approve SOPs, change controls, deviations and CAPAs
- Role eliminated due to company merger
Group Leader / Senior Microbiologist
EUROFINS PSS
Philadelphia, PA
01.2022 - 05.2023
- Led a team of seven PSS scientists in the validation and commercial readiness of cell gene therapy facility in support of client BLA approval process
- Authored SOPs, validation protocols and trending analysis of EM data for microbiological labs
- Served a EM and Microbiology SME during FDA and other regulatory audits
- Led and managed necessary resources to complete validation of cleanrooms and microbiological per client needs
- Authored SOPs, validation protocols and all trend reports of EM data for microbiological labs
- Provided staff supervisory functions in areas of hiring, training, budget, salary negotiations, performance reviews and organizational policies to ensure Team efficiency and Client satisfaction
- Role concluded due to project end
Bioassay Scientist
Merck &Co
North wales, PA
06.2021 - 10.2021
- Conducted real-time flow cytometry assay in support of increased manufacturing process control and consistency in viral growth kinetics for Varicella vaccine bulk manufacturing department
- Participated in the transfer of process analytical technologies (PAT) to cGMP manufacturing facilities, and support implementation and operations in the new PAT laboratory
- Supported process improvements as well laboratory experiments to support technical investigations and implement sustainable long-term solutions
- Contract
Microbiologist
AUROBINDO
E. Windsor, NJ
11.2020 - 05.2021
- Successful validation of new QC micro laboratory and sterile manufacturing facility
- Led the identification and creation of stock and library of all In-house Isolates during EM Validation of entire Facility
- Provided microbiological sampling, testing, and monitoring to assure quality of materials, components, in-process products, finished products, and retained/stability samples
- Assisted in microbiological method development and validation procedures as well as OQ and PQ of equipment such as Maldi Bruker and Isolators.
- Performed data review, summary preparation (trend data, text reports, validation data), investigated, and resolved any QMS incidents in the process, system, facility or documents associated with non-conformances
QC Analyst
LIDESTRI FOODS
Pennsauken, NJ
01.2020 - 04.2020
- Monitored all stages of the operation process and ensured quality of products for brands such as Bai and Monster through microbiological and analytical testing of products and EM
- Contract
QC Analyst
Lab Support
Philadelphia, PA
01.2015 - 01.2018
- Performed Microbiological Testing and analysis of food products with the use of microbiology lab technique
QC Analyst
Apex systems/Lab Support
Philadelphia, PA
01.2014 - 01.2015
- Monitored all stages of the operation process for food products intended for companies including Walmart and Wawa.
- Performed Microbiological Testing and analysis of and Contaminants such in food products as well as determination of spoilage and preservation with the use of microbiology lab technique
- Contract
Pharmacy Technician
JUST HERE PHARMACY
Philadelphia, PA
01.2010 - 01.2014
- Ensured timely processing and delivery of patients prescription as well administrative tasks
- Role concluded due to career change
Education
Master of Business Administration (MBA) - Pharmaceutical and Healthcare Management
SAINT JOSEPH’S UNIVERSITY
Philadelphia, PA01.2023
Bachelor of Science - Biology
TEMPLE UNIVERSITY
Philadelphia, PA01.2014
Skills
- EU Annex 1, FDA Guidance for Industry, USP/EP Chapters, Master Control, Track-wise,
- Veeva Vault, QMS, Microsoft applications ( Excel, Powerpoint, Word)
- Validation and use of Major Microbiological Instruments such as Maldi Bruker, Sterility Isolator systems and Endosafe PTS
- Microbiological Quality Control and Compliance, BLA / IND Submission, Pharmaceutical Global Strategy, Project Management, Risk Management, Data Analytics, Good Manufacutring Practices,
Timeline
Microbiology Team lead
Castle Creek Biosciences
10.2025 - 03.2026
Project Lead / Senior Consultant
AZZUR GROUP LLC
05.2023 - 10.2024
Group Leader / Senior Microbiologist
EUROFINS PSS
01.2022 - 05.2023
Bioassay Scientist
Merck &Co
06.2021 - 10.2021
Microbiologist
AUROBINDO
11.2020 - 05.2021
QC Analyst
LIDESTRI FOODS
01.2020 - 04.2020
QC Analyst
Lab Support
01.2015 - 01.2018
QC Analyst
Apex systems/Lab Support
01.2014 - 01.2015
Pharmacy Technician
JUST HERE PHARMACY
01.2010 - 01.2014
Master of Business Administration (MBA) - Pharmaceutical and Healthcare Management
SAINT JOSEPH’S UNIVERSITY
Bachelor of Science - Biology
TEMPLE UNIVERSITY