Chester French
Cleaning Validation Consultant
Summary
Biopharmaceutical Operations, Quality and Training professional with 30+ years’ experience working in a wide variety of different functional areas within the pharmaceutical, medical device and biopharmaceuticals industries. Exceptional communication skills; demonstrated leadership, and a proven track record of successfully managing global projects and initiatives for domestic and international clients.
Overview
29
29
years of professional experience
2
2
Certifications
Work History
CEO/Principal
QT Savant Inc.
03.2020 - Current
- Owner/Operator of consulting firm providing a wide variety of training and GXP Services for domestic and international biotech/pharma/medical device clients.
- Project: Built Quality System Infrastructures
- Project: Conducted Extensive GXP and Train-the-Trainer Training Programs
- Project: Developed and Executed Failure Investigations Qualification Course for Investigators
- Project: Built GXP Training Infrastructure for International Client
INDEPENDENT CONTRACTOR
Validant, San Francisco, CA
01.2020 - 01.2022
- Tasked with the leadership, strategy and oversight of the Training program and GxP compliance infrastructure for international biopharmaceutical manufacturing client.
- Developed and executed 19 discrete training and qualification programs.
- Developed and refined GXP training infrastructure.
- Mentored and coached internal training designates.
- Project advisor on eLMS implementation and configuration.
DIRECTOR, OPERATIONS EXCELLENCE & TRAINING
Ajinomoto BioPharma Services, San Diego, CA
01.2019 - 01.2020
- Leadership and oversight of Training and Operations Excellence projects for mid-size (600 personnel) biopharmaceutical Contract Manufacturing Organization (CMO).
- Outlined strategy, identified, implemented and directed continuous improvement programs to advance overall business efficiency and performance.
- Established and led cross-functional teams to generate business solutions and cost savings that supported corporate strategies and objectives.
- Project leader for variety of operational improvement programs (i.e. Batch Record Templates, Client Relationship Management Program, Buffer Production Logistics, New Hire Onboarding).
- Introduced and applied standards, conventions and industry best practices.
Biologics Manufacturing Department
SR. MANAGER, BIOLOGICS
01.2015 - 01.2019
- Management and oversight of the Drug Substance Manufacturing Group consisting of Upstream, Downstream, Support Services and Process Engineering.
- Oversee the Biologics Manufacturing operations consisting of microbial and yeast fermentations up to 1000L scale through Downstream operations and bulk drug substance final formulation.
- Outlined strategies and implemented process improvements and efficiency enhancements for department.
- Expanded and developed the capabilities of 54 personnel.
- Project lead for several Operational Excellence projects (Technical Training, Client Service, Operational Metrics, Operator Error Deviation Analysis & Reduction)
ASSOCIATE DIRECTOR, LEARNING SERVICES
Pharmaceutical Process Development (PPD), Middleton, WI
01.2013 - 01.2015
- Oversaw the strategy, development and execution of training programs for the global cGMP Laboratories Division (1,100 personnel).
- Mentored and developed capabilities of a global staff of nine staff.
- Project Leader - Employee Engagement & Career Development, Global Training Analytics, SharePoint Intranet.
INDEPENDENT CONTRACTOR - TRAINING
Merck Vaccines, West Point PA
01.2012 - 01.2013
- Supported all training activities for Technical Operations Engineering (~150 personnel).
- Authored a series of 11 Computer-Based-Training (CBT) modules on a variety of technical training topics.
INDEPENDENT CONTRACTOR - TRAINING
Sandoz Gmbh, Unterach am Attersee, Austria
01.2011 - 01.2012
- Conducted FDA Remediation work for international client as Manager of GMP Training.
- Built complete cGXP training infrastructure – drafted SOPs, developed curricula, implemented eLMS, integrated training and metrics into operations, developed, implemented and conducted technical and on-the-job training programs.
- Mentored and developed training staff of five personnel.
MANAGER, SITE TRAINING
MedImmune LLC, Frederick MD
01.2009 - 01.2011
- Developed and instituted series of comprehensive instructor-led training modules to broadly enhance understanding of scientific principles – Analytical Testing, QC Sampling & Testing, Statistics, Aseptic & Classified Cleanroom Practices, Chromatography Gowning, Cleaning Validation, CIP & SIP, Bioreactors, and Environmental Monitoring.
- Received Director’s Award for efforts with Corporate SAP software conversion project; Site achieved objective of 100% personnel trained on SAP systems ahead of deadline.
- Charged with leading the site Preapproval Inspection preparation program. Developed and conducted sessions for 350 personnel prior to a PAI which yielded zero 483s.
- Led efforts to “forensically deconstruct” on-the-job and technical training in Operations, reducing operator error and product scrap 22% year-over-year.
MANAGER, GCP COMPLIANCE & TRAINING
Amylin Pharmaceuticals, San Diego CA
01.2006 - 01.2009
- Collaborated with Physicians, RNs, Scientists and Pharmacists to develop and implement comprehensive and compliant GCP training and personnel development programs.
- Created and compiled post-marketing pharmacovigilance reports for medical professionals.
MANAGER, CORPORATE COMMUNICATIONS
Biogen Idec, San Diego CA
01.2003 - 01.2005
- Developed Executive, Marketing and Human Resource communications programs and strategies for worldwide multinational organization.
- Content author and administrator for all forms of worldwide broadcast communications media for world’s fourth largest biopharmaceutical company.
MANAGER, cGXP TRAINING
IDEC Pharmaceuticals, San Diego CA
01.1999 - 01.2003
- Built cGXP Training Department and programs for the company. Developed and conducted all manner of cGXP and specialized training.
- Project Manager for implementation of computerized cGMP training records database (ISOTrain) that converted 200,000 paper records to electronic for ~1,000 personnel.
- Managed staff of seven in the domains of cGXP training, internal and external cGMP and vendor auditing and records processing.
SENIOR SHIFT SUPERVISOR
IDEC Pharmaceuticals, San Diego CA
01.1997 - 01.1999
- Managed a staff of five in a Class 100,000/10,000 CBER-licensed biopharmaceutical manufacturing facility.
Education
Masters of Business Administration (MBA) Degree - Marketing, Management
SAN DIEGO STATE UNIVERSITY
Bachelor of Science Degree - General Biology
UNIVERSITY OF CALIFORNIA, SAN DIEGO
Skills
- Technical & cGXP Training
- GXP Quality Systems
- Regulatory Inspection Hosting
- E-Learning Authoring Programs
- Project & Program Management
- Writing Technical Documents
- FDA Remediation
- Enterprise Software Administration
- Vendor Audits
- GXP, EU, QSR, ICH Compliance
- CAPAs/Failure Investigations
- Aseptic & Cleanroom Practices
- Talent development
Certification
Director’s Award ($5,000) – MedImmune 2011
Training
- Good Manufacturing Practices (GMP)
- Good Documentation Practices (GDP)
- Aseptic Practices
- Batch Record Review
- Change Control
- Corrective & Preventative Actions (CAPA)
- Conducting Failure Investigations
- Data Integrity and Scientific Misconduct
- Environmental Monitoring
- Root Cause Analysis (RCA)
- Quality Risk Management (QRM)
- Regulatory Inspection Readiness
Timeline
CEO/Principal
QT Savant Inc.
03.2020 - Current
INDEPENDENT CONTRACTOR
Validant, San Francisco, CA
01.2020 - 01.2022
DIRECTOR, OPERATIONS EXCELLENCE & TRAINING
Ajinomoto BioPharma Services, San Diego, CA
01.2019 - 01.2020
Biologics Manufacturing Department
SR. MANAGER, BIOLOGICS
01.2015 - 01.2019
ASSOCIATE DIRECTOR, LEARNING SERVICES
Pharmaceutical Process Development (PPD), Middleton, WI
01.2013 - 01.2015
INDEPENDENT CONTRACTOR - TRAINING
Merck Vaccines, West Point PA
01.2012 - 01.2013
INDEPENDENT CONTRACTOR - TRAINING
Sandoz Gmbh, Unterach am Attersee, Austria
01.2011 - 01.2012
MANAGER, SITE TRAINING
MedImmune LLC, Frederick MD
01.2009 - 01.2011
MANAGER, GCP COMPLIANCE & TRAINING
Amylin Pharmaceuticals, San Diego CA
01.2006 - 01.2009
MANAGER, CORPORATE COMMUNICATIONS
Biogen Idec, San Diego CA
01.2003 - 01.2005
MANAGER, cGXP TRAINING
IDEC Pharmaceuticals, San Diego CA
01.1999 - 01.2003
SENIOR SHIFT SUPERVISOR
IDEC Pharmaceuticals, San Diego CA
01.1997 - 01.1999
Bachelor of Science Degree - General Biology
UNIVERSITY OF CALIFORNIA, SAN DIEGO
Masters of Business Administration (MBA) Degree - Marketing, Management
SAN DIEGO STATE UNIVERSITY
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