Sector Experience
Healthcare
Consumer Goods
Life Sciences & Pharma
26
years
Years of Experience
10/20
Member Since
Fortune 500
Experience
Allen Regulatory Consulting Group
Management Consulting
Independent Consultant
Performing quality systems, regulatory, and process improvement consulting and assistance for dietary supplement, pharmaceutical, medical device, and cosmetic manufacturers and distributors including:
o FDA cGMP compliance including 483 response plans
o Certification and compliance gap analyses
o Onsite audits and training
o QMS development including SOP creation and process implementation
o Label and formula reviews
o Regulatory compliance, review, risk analysis, and registration
o FDA cGMP compliance including 483 response plans
o Certification and compliance gap analyses
o Onsite audits and training
o QMS development including SOP creation and process implementation
o Label and formula reviews
o Regulatory compliance, review, risk analysis, and registration
Kleen Concepts
Product Management / Strategy
General Manager
-Lead operations for a personal care contract manufacturer including:
o Quality & Regulatory
o Product Development & Onboarding
o Customer Service and Purchasing
o Graphic Arts
o Production
o Warehouse & Logistics
-Developed and implemented all KPIs, COTs, Cost Standards, and Dashboards driving performance
o Quality & Regulatory
o Product Development & Onboarding
o Customer Service and Purchasing
o Graphic Arts
o Production
o Warehouse & Logistics
-Developed and implemented all KPIs, COTs, Cost Standards, and Dashboards driving performance
Kleen Concepts
Product Management / Strategy
Sr. Quality Systems Manager
• Lead implementation of QMS and GMPs in compliance to ISO 22716
• Implemented and improved quality control process and personnel
• Drove and maintained USDA NOP and NSF Organic Certification
• Implemented and improved quality control process and personnel
• Drove and maintained USDA NOP and NSF Organic Certification
Arizona Nutritional Supplements
Product Management / Strategy
Director of Laboratory Services
• Lead a team of 27 scientists and technicians in a high volume and high paced lab performing quality release testing and method development for nutritional supplements in compliance with 21 CFR part 111.
• Capabilities included microbiology, HPLC, HTLC, IR, and ICP/GC-MS
• Drove all laboratory continuous improvement projects including lean six sigma projects and kaizens leading to an increase in lab OTD of testing of over 35%.
• Capabilities included microbiology, HPLC, HTLC, IR, and ICP/GC-MS
• Drove all laboratory continuous improvement projects including lean six sigma projects and kaizens leading to an increase in lab OTD of testing of over 35%.
DuPont Nutrition and Health
Product Management / Strategy
Quality Control Manager
• Managed a team of QC microbiology technicians at two site laboratories in an ISO 22000 and 9001 certified large-scale fermentation probiotics plant.
• Lead quality troubleshooting teams driving FPFQ from 80% to over 97% and contamination rate from 13% to under 2%
• Lead CCP and oPRP validations including CIP, SIP, COP processes
• ISO 9001 and 22000 internal auditor; HACCP Manager and PCQI Certified
• Lead quality troubleshooting teams driving FPFQ from 80% to over 97% and contamination rate from 13% to under 2%
• Lead CCP and oPRP validations including CIP, SIP, COP processes
• ISO 9001 and 22000 internal auditor; HACCP Manager and PCQI Certified
Moog Medical Devices Group
Product Management / Strategy
Senior Microbiologist
• Oversaw a team of 14 technical personnel in a high-paced contract laboratory performing various USP, EP, and ISO microbial assays including: antimicrobial efficacy testing, zone of inhibition assays, minimum effective concentration, environmental monitoring, bioburden, sterility, and D value testing.
• Directed gamma, EtO, and steam sterilization validations and product packaging qualifications.
• Wrote and approved protocols, work instructions, and controlled documents.
• Directed gamma, EtO, and steam sterilization validations and product packaging qualifications.
• Wrote and approved protocols, work instructions, and controlled documents.
Moog Medical Devices Group
Product Management / Strategy
Microbiologist I & Microbiology Technician III
-Performed complex ISO and FDA 510k microbial testing including:
o Microbial ingress and contact lens solution assays
o Shelf life and stability testing
o Microbial differentiation and identification
-Performed routine QC microbiology testing supporting medical device and pharmaceutical release
-Maintained stock cultures, incubators, and laboratory instruments
o Microbial ingress and contact lens solution assays
o Shelf life and stability testing
o Microbial differentiation and identification
-Performed routine QC microbiology testing supporting medical device and pharmaceutical release
-Maintained stock cultures, incubators, and laboratory instruments
Bausch & Lomb
Product Management / Strategy
Microbiology Technician III
-Supported solution and lens manufacturing areas
-Performed USP antimicrobial efficacy, biocidal, bioburden, sterility, and regimen testing on lenses and cleaning and storage solutions
-Validated steam sterilization processes and contact lens cleaning solution effectiveness
-Performed USP antimicrobial efficacy, biocidal, bioburden, sterility, and regimen testing on lenses and cleaning and storage solutions
-Validated steam sterilization processes and contact lens cleaning solution effectiveness
Johnson & Johnson
Product Management / Strategy
Nucleic Acid Diagnostics Technician III
-Supported assay development of PCR diagnostic tests for oncological K-ras mutations, HIV-DNA and RNA, Cytomegalovirus, Hepatitis C Virus, Mycobacterium tuberculosis, and Mycobacterium avium complex assays
-Co-Invented method of DNA extraction from paraffin embedded tissue using a thermophilic protease and heat (Patented in US and Europe).
-Co-Invented method of DNA extraction from paraffin embedded tissue using a thermophilic protease and heat (Patented in US and Europe).