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
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Member of Annual Meeting Program Committee (2006 – 2012)
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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
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Bulletproof Documentation/RevZero June 2018 - present
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Jeff Yuen & Associates July 2017 – present
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Exemplar Compliance July 2017 – present
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MWA Consulting, Inc March 2016 - present
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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.
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Responsible for standardizing/aligning QC practices across global sites: included lab practices, process for
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Design Operations global cGMP training program.
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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.
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Division representative on company merger projects.
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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.
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Project management oversight for product transfer from one site to another.
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Provide coaching and mentoring on technical and leadership competencies across global sites.
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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.
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Created company Specifications Committee and served as Chair, providing guidance for laboratory and product trend reviews.
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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.
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Ensure compliance where applicable to CBER, CDRH, ISO & Industrial products for laboratory control systems, equipment and method validations, method transfer and failure investigations.
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Member of global teams involving method, equipment and product evaluations and transfers.
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Responsible for global system implementation (e.g. LIMS, Specifications Committee, Risk Management),
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Provide coaching and mentoring for staff in compliance, technical and leadership competencies.
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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.
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Responsible for animal testing facility including veterinarian.
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Chair of Specifications Committee.
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Signatory approval for QC testing Certificate of Analysis.
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Primary department contact for audits/inspections.
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Provide frequent communication to CBER concerning product testing and proposed supplements.
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Provide guidance and resources to achieve and maintain compliance for laboratory control systems, including equipment/method validations and methods transfer.
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Responsible for system implementation (e.g., LIMS, Specifications Committee, documentation).
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Member of product comparability and project steering teams.
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Lean Six trained and a sponsor for green belt (staff) projects.
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Select Agent Clearance.
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Participant in Management Development and Leadership Programs.
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Manage Compliance, Release and Logistics functions for QC BioPharma and LIMS.
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Chair of commercial product Specifications Committee.
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Responsible for QC commercial product quarterly trend reviews and year end reports.
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Participate in LIMS design, implementation, change control and validation.
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Primary department contact for audits/inspections.
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Maintain compliance per ICH, FDA, EU, ROW, Canada, WHO, ISO, USDA and OSHA regulations,
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Participate in choosing, designing & implementing a global electronic document management system.
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Perform gap analyses and help create corresponding SOPs, guidance documents, and company policies.
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Participate on Quality Improvement Teams/sponsored one of the first Continuous Improvement Teams.
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Establish the QC Therapeutic Bioassay, Immunoassay and DNA QC testing labs.
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Responsibility for Electrophoresis testing group.
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Co-author initial Corporate OOS policy.
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Department internal compliance coordinator.
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Participate in Therapeutics regulatory inspections, responses and assure compliance with ICH guidelines.
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Author CMCC/ PLA/BLA/IND sections.
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Oversee internal and external method and technology/write method validation and equipment IQ/OQ/PQ plans/protocols/reports and SOPs.
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Participate in design and implementation teams for LIMS, Documentum, SAP, sample tracking/bar coding and electronic notebook projects.
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Participate in lot release, with and without LIMS.
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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.
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Develop, manufacture and provide the 510K validation/documentation for the second generation Microgenics CEDIA™ digoxin assay kit.
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Led assay development and transfer team for T3 assay.
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Wrote the in-house training manual for the clinical equipment.
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Helped write the company Safety Handbook and was Radiological Safety Officer.
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Design, perform and evaluate in vivo erythropoietin (epo.) animal studies, and perform epo RIAs for the NIH and Amgen.
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Grew and maintained species cotton and determined photosynthetic rates using gas chromatography.
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Assist in electron microscopy studies for guayule and plant growth regulator studies.
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Ran biomass studies and assay optimizations, attempted immobilized enzyme study.
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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