EDUCATION, CERTIFICATION & PROFESSIONAL ASSOCIATIONS
M.S. Biochemistry | Texas A&M University, College Station, TX (Phi Sigma member) December 1978
B.S. Biology | University of Maryland, College Park, MD May 1976
Certified Full Instructor (Biology) | California Community College System
Parenteral Drug Association 1989 – 2013, 2015 - present
Member of Annual Meeting Program Committee (2006 – 2012)
Moderator for Process Analytical Technology sessions (2011 & 2012)
Society for Laboratory Automation & Screening 2012 – 2013
San Diego Regulatory Affairs Network 2012 – 2013
PROFESSIONAL EXPERIENCE:
Independent Consultant and Associations with March 2016 – present
Bulletproof Documentation/RevZero June 2018 - present
Jeff Yuen & Associates July 2017 – present
Exemplar Compliance July 2017 – present
MWA Consulting, Inc March 2016 - present
Global business owner responsible for defining policies & implementation of LIMS: responsible for interviewing and approving IT project manager, forming global user teams, identifying/helping prioritize requirements and writing system user requirements, identifying and guiding the choice of the LIMS platform, all system requirement and validation documentation approval.
Responsible for standardizing/aligning QC practices across global sites: included lab practices, process for
Design Operations global cGMP training program.
Provide participation and back-up support for global Quality Assurance in areas of: 1) Executive Management Committee, 2) Material Review Board, 3) site regulatory inspections, external and internal, domestic and international, 4) auditing and pre- approval inspections of suppliers and contract manufacturers, 5) deviation, failure investigations, OOS resolution, effectiveness of corrective action, 6) supplier qualification, and 7) training.
Division representative on company merger projects.
Member on global teams involving documentation management solution choice, product and assay transfer requirements, product and equipment validation process requirements. Provide final documentation signatory approval.
Project management oversight for product transfer from one site to another.
Provide coaching and mentoring on technical and leadership competencies across global sites.
Responsible for Microbiology/Environmental Monitoring, Quality Control (biological, chemistry), Raw Materials, QC Systems (laboratory software & hardware), and Stability and Specifications departments: provide guidance and final approval of processes and systems to ensure compliance to domestic and international standards and requirements.
Created company Specifications Committee and served as Chair, providing guidance for laboratory and product trend reviews.
Provide participation and back-up support for global Quality Assurance in areas of: 1) Quality Executive Management Committee, 2) Material Review Board, 3) corporate Quality Policy establishment and implementation, 4) site-specific Quality Policy establishment and implementation, 5) site regulatory inspections, external and internal, domestic and international, 6) auditing and pre-approval inspections of suppliers and contract manufacturers, 7) deviation, failure investigations, OOS resolution, effectiveness of corrective action and 8) training.
Ensure compliance where applicable to CBER, CDRH, ISO & Industrial products for laboratory control systems, equipment and method validations, method transfer and failure investigations.
Member of global teams involving method, equipment and product evaluations and transfers.
Responsible for global system implementation (e.g. LIMS, Specifications Committee, Risk Management),
Provide coaching and mentoring for staff in compliance, technical and leadership competencies.
Responsible for Animal Resources, Microbiology/Environmental Monitoring, Quality Control Chemistry & Raw Materials Testing, QC Systems (logistics & LIMS), Stability and Specifications, and interim responsibility (5 months) for Lansing site Quality Systems and Regulatory Affairs.
Responsible for animal testing facility including veterinarian.
Chair of Specifications Committee.
Signatory approval for QC testing Certificate of Analysis.
Primary department contact for audits/inspections.
Provide frequent communication to CBER concerning product testing and proposed supplements.
Provide guidance and resources to achieve and maintain compliance for laboratory control systems, including equipment/method validations and methods transfer.
Responsible for system implementation (e.g., LIMS, Specifications Committee, documentation).
Member of product comparability and project steering teams.
Lean Six trained and a sponsor for green belt (staff) projects.
Select Agent Clearance.
Participant in Management Development and Leadership Programs.
Manage Compliance, Release and Logistics functions for QC BioPharma and LIMS.
Chair of commercial product Specifications Committee.
Responsible for QC commercial product quarterly trend reviews and year end reports.
Participate in LIMS design, implementation, change control and validation.
Primary department contact for audits/inspections.
Maintain compliance per ICH, FDA, EU, ROW, Canada, WHO, ISO, USDA and OSHA regulations,
Participate in choosing, designing & implementing a global electronic document management system.
Perform gap analyses and help create corresponding SOPs, guidance documents, and company policies.
Participate on Quality Improvement Teams/sponsored one of the first Continuous Improvement Teams.
Establish the QC Therapeutic Bioassay, Immunoassay and DNA QC testing labs.
Responsibility for Electrophoresis testing group.
Co-author initial Corporate OOS policy.
Department internal compliance coordinator.
Participate in Therapeutics regulatory inspections, responses and assure compliance with ICH guidelines.
Author CMCC/ PLA/BLA/IND sections.
Oversee internal and external method and technology/write method validation and equipment IQ/OQ/PQ plans/protocols/reports and SOPs.
Participate in design and implementation teams for LIMS, Documentum, SAP, sample tracking/bar coding and electronic notebook projects.
Participate in lot release, with and without LIMS.
Developed and validated: pharmacokinetic immunoassays, process impurity/cleaning assays, DNA/RNA hybridization probes and dot/slot blot assays, product & process immunoassays, bioassays, and evaluated new techniques and equipment.
Develop, manufacture and provide the 510K validation/documentation for the second generation Microgenics CEDIA™ digoxin assay kit.
Led assay development and transfer team for T3 assay.
Wrote the in-house training manual for the clinical equipment.
Helped write the company Safety Handbook and was Radiological Safety Officer.
Design, perform and evaluate in vivo erythropoietin (epo.) animal studies, and perform epo RIAs for the NIH and Amgen.
Grew and maintained species cotton and determined photosynthetic rates using gas chromatography.
Assist in electron microscopy studies for guayule and plant growth regulator studies.
Ran biomass studies and assay optimizations, attempted immobilized enzyme study.
Assisted in the in vivo evaluation of pollutants using environmental chambers.
Hologic / Gen-Probe | San Diego, CA June 2006 – May 2013
In vitro Diagnostic/Medical Device Quality Control
Senior Director Enterprise QC Systems (Reporting to SVPs of Operations and IT)
specification setting, training, documentation presentation.
Senior Director/Director Quality Control (Reporting to Senior VP of Operations)
Emergent BioSolutions / BioPort | Lansing, Michigan November 2004 – June 2006
Vaccine Quality Control
Director of Quality Control & Animal Resources (Reporting to VP of Quality & Regulatory Affairs)
Independent Consultant March 2004 – November 2004
Chiron / Cetus | Emeryville, CA March 1987 – March 2004
BioTherapeutics Quality Control
Associate Director Compliance, Release & Logistics (Reporting to Director of Quality Control)
Associate Director / Manager QC Laboratory Operations (Reporting to Director of Quality Control)
Analytical Development Research Associate (RA) II / RA I (Reporting to Director of Analytical Development)
Microgenics Corp | Concord, CA May 1985 – March 1987
In vitro Diagnostic Development
Immunodiagnostic Chemist (IC) II / IC I (Reporting to Manager of Development)
Lawrence Berkeley Laboratory | Berkeley, CA May 1983 – May 1985
NIH Research
Senior Research Associate
Texas A&M University
College Station, TX October 1980 – May 1983
Plant Sciences Research
Technician II / Tech I
Lawrence Berkeley Laboratory May 1979 – August 1980
EPA Pollution Research
Senior Research Associate
MISCELLANEOUS EXPERIENCE
Biological Technician (gas chromatography); USDA, Albany, CA February 1979 - May 1979
Teaching Assistant; Texas A&M University, Dept. of Biochemistry & Biophysics Sept 1976 – Sept 1978
(research techniques included electron microscopy, raising/obtaining/purifying antibodies, beta-test for Beckman HPLCs) Student Worker; Bureau of Mines & Botany Dept, Univ. of MD January 1974 - July 1976