EXPERIENCE HIGHLIGHTED
GER Compliance
Fenton, MO
Industry Consultant
Nov 2020
Performed two-day on-site for internal QMS audit
API CRO
GMP facility and laboratory tour
Manufacturing, Data Integrity, Analytical Chemistry Laboratory and Microbiology audit & document review
Delivered a report on conformances/non-conformances
GER Compliance
Fenton, MO
Industry Consultant
Aug 2020
Performed one-day remote vendor requalification audit
CRO
GMP facility tour via PowerPoint
Data Integrity audit using secure web cloud site for
document review
Delivered a report on conformances/non-conformances
PSC Biotech
Pomona, CA
Validation Engineer Consultant
Feb 2020 – Jun 2020
- Senior Validation Engineer Consultant
Data Integrity Audit
Authored and revised SOPs for QC Laboratory
UV/Vis and CE Instruments
Responsible for protocol execution requiring interface and coordination with Validation Contractor
Established remote sandbox computer with the vendor for evaluating Installation Qualification and the writing and testing the Operation SOP Administrative System Management SOPs
NBTY
Ronkonkoma, New York, Consultant
March 2019 – July 2019
- Interim Laboratory Manager
FDA Inspection Readiness & GMP Remediation
- Ran the day to day operation of the lab. Test, outsource, investigate, release and retain laboratory samples. Supervise and mentor Supervisors and Manager. Align and train, manage and develop chemists and technicians to 21 CFR Part 111 CGMP for Dietary Supplements.
Established Environmental, Health & Safety laboratory team for the handling, storage and disposal of solvent and waste
Reorganized Chemical storage based on OSHA GHS and ACS color systems.
Revised First Aid and Fire Evacuation Protocols
Two Supervisors 1st/2nd Shift
Twenty-Four Analysts
Instrumental and Wet Chemical USP monograph and In-House methods
Two Lead Chemists
Four Senior Chemists
Four Chemist I
Four Chemist II
Ten Lab Technicians
- Analytical Laboratory Instrumentation Lab
Waters HPLC/UPLC - MS/UV/VIS/Fluorescence/DAD
Perkin Elmer ICP/MS/AES
Perkin Elmer GC
Perkin Elmer FTIR
Bruker NIR
Perkin Elmer UV/Vis
Distek Dissolution/Disintegration
Leco Protein Analyzer
Microbiology Manager
Six Microbiologists
Two Microbiology Technicians
- Documentation Coordination Group
One Supervisor
Five Document Coordinators
Reorganized sample handling & management lifecycle to day of week
Established and prioritized document control system along day of week/category
Coordinated and remediated outsourcing program
- FDA Inspection Readiness & GMP Remediation
Established and led teams to:
Organize the facility and equipment
Decommissioned and upgraded equipment
Repair and maintain infrastructure (Fume Hoods, Utilities, Benches)
Update and document training records
Revised Laboratory SOPs to align with 21 CFR Part 111 CGMP for Dietary Supplements
Achieved United Laboratory (UL) certification for the laboratory
- Data Integrity, Good Documentation Practices, Electronic Record Lifecycle
Instituted and aligned electronic chromatography data protocols with 21 CFR Part 11
Established and led teams to:
Evaluate standalone instruments for Part 11 compliance and either were upgraded, replaced or decommissioned
Evaluate Software for Part 11 Compliance in the following laboratory/quality systems:
Document Controls
Change Controls
Investigations – Unplanned Deviations
Investigations – Planned Deviations
Zochem, LLC
Brampton, ON
Consultant
Feb 2019 – Dec 2019
- Provide training on ICH Q7 API GMP.
- Trained executive management team on ICH Q7 API GMP
- Presented training assessment to QA leadership for them to train site personnel.
- Remediate analytical testing by ICP/AES and Atomic Absorption for USP monograph impurities in Atypical Active Ingredients - USP
- Provide continuous support for Health Canada inspection readiness for Atypical Active Ingredients – USP manufacturing
Pharma Tech Industries
Union, MO
Consultant
Feb 2019
- Provide instrument qualification and validation, 21 CFR Part 11 and CSV, method development, program implementation and support for real time raw material inspection using Raman spectroscopy.
- Worked with client quality control department to review and write method validation protocols, method validations, risk assessment.
- SOPs and delivery of device training for reduced testing program.
- Model and analyze data for compliance to establish specifications
Doramaxx
Goldens Bridge, NY
Consultant
June 2016 – Present
- Co-developer of consumer safety device using 510K medical device instrument
- Requirements for design specifications
- Implementation of multivariate analysis on human subjects for the analysis of physiological states using remote sensing technology
- Develop and design clinical trials for device testing
- Model and analyze data for compliance to establish specifications
- Provide continuous support for training and consulting to domestic and international pharmaceutical concerns for adoption of new technologies for drug manufacturing
KIK
Elkhart, IN
Lead Consultant
April 2016 – Feb 2017
- Lead consultant to client providing instrument qualification and validation, method development, program implementation and support for real time raw material inspection using Near Infrared and Raman spectroscopy.
- Primary focus was to provide oversight on the development of the sampling program, computer system validation and systems training, worked with client quality department to write SOPs for program OOS investigations.
- CAPA implementation, auditing, risk assessment, program management and delivery of GDP training for reduced testing program.
- Subject matter expert on filing annual product review update on the use of new technology for raw material identification using spectroscopy and multivariate methods.
- Served as consultant and subject matter expert in spectroscopy and chemometric for operational and performance qualification, computer system validation and quality requirement documentation (e.g. user requirements, risk assessment, Part 11 assessment and traceability matrix) for raw material identification by Raman and NIR spectroscopy.
- Audited site for CGMP compliance and alignment to 21 CFR 11, 210 and 211 and FDA guidance.
- Provided site remediation and training for related CGMP requirements for reduced testing program.
- Implement and instruct quality assurance on interim controls and remediation of their quality systems management approach for CGMP.
Dynalabs, LLC
St. Louis, MO
Director of Operations (Consultant)
Sep 2015 – July 2017
- Implemented operational excellence principles to effect continuous improvement that resulted in $1M monthly revenues in less than one year and multiple and consecutive $1M monthly revenues since then. Specific deliverables are:
- Revised and created new standard operating procedures to train or retrain, empower staff, samples and information to reestablish accountability and enhance customer service. Achieved 100% sample delivery to their intended targets and sample testing. Working with microbiology and chemistry managers and supervisors, he focused those teams on optimizing people performance, correcting, creating or eliminating process controls and creating or modifying procedures (SOPs) to attempt to effect 0% deviation, IR's and 0% sample loss with dramatic gains being made in all three divisions.
- Incorporated management and operation excellence tools into his toolbox that relate back to the following management categories: Planning, Budgeting and economic management, work flow and organization, compliance, problem solving, evaluation and control and finally risk management. The operations management team led by the COO and the Director of Operations managed several major initiatives in chemistry, microbiology and sample management in last quarter of 2015 and the first through third quarter 2016.
- Relocated the chemical laboratory from the first floor to the second floor with minimum impact from January 2016 until August 2016, Gary has refocused his efforts on incorporating management tools into his toolbox that relate back to the following management categories: Planning, Budgeting and economic management, work flow and organization, compliance, problem solving, evaluation and control and finally risk management. Gary and the operations management team are managing several major initiatives in chemistry, microbiology and sample management.
- Led the creation, development and implementation of the environmental, health and safety (EH&S) program impacting sample management, microbiology and chemistry operations. System optimization included solvent and waste transport from 1st to 2nd floor and vice versa using the elevator, solvent management and storage in the laboratory and media destruction management resulting in eighteen thousand dollars ($18k) savings annually.
- Gary was responsible for the creation and management of EHS systems at Dynalabs, Previously Gary performed bi-annual auditing, established and maintained robust, complete and compliant environmental, health and safety (EHS) program that led to the reduction or eliminated exposure of hazardous chemicals, biochemical and radioactive agents to employees and the environment. He implemented OSHA program Zero Accident Vision based on establishing a culture of workplace safety, training employees to identify critical hazard points, classifying waste streams based on OSHA and EPA requirements, managed fire safety program and emergency evacuation routes.
- Led chemistry personnel in setting up, implementing and organizing the laboratory using the 5S system.
- Facilitated coordinating the Quality Assurance/Laboratory Operations Investigational Reporting of OOS by helping to repurpose a key analyst to quality to help minimize and facilitate closing of OOS issues in the chemistry laboratory.
- Microbiology underwent a dramatic staff turnover and Director of Operations worked with the management team to help facilitate and guide them through to stabilization period. With many controls implemented to minimize and eliminate sample loss, he has been managing with the microbiology and executive management team, phase II expansion, new testing services, EHS and waste programs, and coordinating application of testing new decontamination steps in the clean room.
- Sample management has seen the most change with the coordinating and training on the newly implemented bar coding system which brought with a major change in how samples are handled. This required major revisions to the sample management SOPs and these have all been written and revised. Staffing was a challenge but with management's assistance, staffing was brought under control.
- Facilitated research and marketing for outsourcing testing on biologic compounds, developing, auditing and establishing a partnership with a leading domestic laboratory.
- Facilitated research and marketing for testing state regulated cannabis products. Provided due diligence on current capacity, competitor pricing and market forecast
Central India Ethanol
Marion, IN
Lead Consultant
Feb 2015 – March 2015
- Support cGMP and Preventative Controls implementation of Food Safety Modernization Act (FSMA) at the manufacturing facility. Provided cGMP audit and gap analysis of quality system.
- Provide support for quality group for cGMP training, process equipment and laboratory instrument qualification and analytical method validation.
- Trained senior management team on current good manufacturing practice.
- Instruct senior management team on instituting quality systems management approach for manufacturing and laboratory facilities.
- Write and train staff on standard operating procedures (SOPs) for management responsibility, quality management system policy, standard operating procedures and SOP template.
- Ongoing support for SOP writing and reviewing, quality management, and continuous auditing for compliance to FSMA and cGMPs.
MERCK
White House Station, NJ
Consultant
Dec 2013 – July 2014
- Consultant contractor supporting Process Analytical Technology (PAT) Group to create a benchmarking report for the use of PAT tools for cell culture and fermentation processes. The assignment required gap analysis of current internal practices, researching current industry practices, regulatory expectations and literature and patent review of PAT tools for biopharmaceutical manufacturing.
- Met with an FDA scientist and biopharmaceutical subject matter expert and he led
- discussions over a period of four months.
- Visited and met with scientists at Fort Detrick, a US Government laboratory installation.
- Assessed conversations held with Roche employees to identify gaps in current
- manufacturing processes that could lead to incorporation of PAT tools.
- Researched literature for regulatory expectations of PAT use in biopharmaceutical manufacturing.
- Wrote a report with consulting team that included my input of regulatory expectations that identify benchmarks for assessing and implementing PAT tools for Roche biopharmaceutical manufacturing operations.
Infratrac
Silver Spring, MD
Director of Scientific Affairs (Consultant)
April 2009 – Present
- A woman-owned venture capital startup.
- Joined company full time December 2013.
- Provided in-house scientific expertise with hands-on pharmaceutical industry experience.
- Provided management and its clients with advice, support, and leadership in the creation, coordination and delivery of Anti-Counterfeiting solutions, Hospital verification system setup, Analytical instruments, and Consultation, Training and Support programs and services.
- Implemented Scientific Affairs strategy structured to guide the development of programs and services through Operations and Project Support as well as Life-cycle management.
- Demonstrated industry leadership with expertise in developing, directing and coordinating innovative analytical solutions in pharmaceutical analysis for regulatory pharmaceutical compliance.
- Evaluated Near Infrared spectrometer for suitability of pharmaceutical analysis for regulatory compliance.
- Explored specialty coatings for packaging materials and developed proprietary procedures for manufacturing and detection.
United States Pharmacopeia
Rockville, MD
Scientist Fellow
June 2003 – April 2009
- Served as liaison for United States Pharmacopeia, General Chapters, Pharmaceutical Waters, and Statistics Expert Committees, plus additional international government agencies and the pharmaceutical industry.
- Worked to establish parameters for management consideration of Process Analytical Technology to compendial policy.
- Recommended experts in spectroscopy and analytical chemistry to populate General Chapter and Reference Standards Expert Committees.
- Managed study as lead investigator on multi-laboratory project including U.S. FDA and private laboratory.
- Supervised study for the development of Near Infrared Spectral Libraries on multiple NIR spectrophotometers.
- Developed, drafted and directed study protocol; drafted instrument and model standards for developing, maintaining, and transferring chemometric methods between laboratories.
- Represented USP at PAT related symposia, conferences, and USP sponsored events.
- Led efforts to develop, revise, and publish the final USP General Chapter on Near Infrared Spectroscopy
- Oversaw 30 new and revised general and informational chapters.
- Developed nine pharmaceutical water monographs, three general and informational chapters, and two new and revised general and information chapters.
- Lead Scientist / Liaison for inter-agency NIR study (USP / FDA). Managed study as lead investigator on multi-laboratory project including U.S. FDA and private laboratory.
- Supervised study for the development of Near Infrared Spectral Libraries on multiple NIR spectrophotometers. Developed, drafted and dire ted study protocol; drafted instrument and model standards for developing, maintaining, and transferring chemometric methods between laboratories. Joint USP peer reviewed paper published with FDA; Irvine Pharmaceutical Services, Inc. And Buchi
EDUCATION
Bachelor of Arts in Biology, 1980
University of Bridgeport, CT
Master of Science in Biology, 1982
University of Bridgeport, CT