Providing expert leadership and planning to companies seeking to obtain GMP manufacturing licensing through California Food and Drug Branch and/or pre-approval inspections by FDA.GMP Training (21 CFR 210-211), Data Integrity Training (FDA, WHO, MHRA), FDA Pre-Approval Inspection Training, Preparation of Facilities and Quality Systems for Inspection by California Food and Drug Branch, Mock Inspections of Manufacturing Facilities, Audits of Medical Device Manufacturers, On-site Supplier Qualification. Authoring of Quality Systems to support GMP testing, Production, Raw Materials, Receiving/Distribution, Material Review Board, Out of Specification Investigations, Equipment and Utility Systems. Perform internal audits (third party), identification of issues/growth areas, remediation of deficiencies. Remediation of FDA 483s for clients with OTC and commercial pharmaceutical productsNasal spray products - Analytical Review, OOS investigations, drug substance and drug product manufacturing, nasal spray pump and actuator troubleshooting, etc.

• Promoted to this position by the Chief Executive Officer and President. • Directly responsible for meeting or exceeding departmental monthly/annual revenue goals for all departments. Directly manage the projects and employees of the Analytical Development, Quality Control, Project Management, Manufacturing and Facilities departments and co-managed the Formulations department together with the Chief Science Officer.• Created, implement, and manage the budgets for six departments.• Collaboration with BioDuro sites in Beijing and Shanghai to establish Global CMC Solutions parent division contributing to the development of business strategy and focus for sites in China and the U.S. Assessed the cGMP compliance of Chinese divisions.

Quality Assurance - Focused on continuous improvement of BioDuro's Quality Systems to meet the compliance needs of our clients and current requirements of regulatory agencies. BioDuro's QA provides internal audit and client audit support, vendor qualifications, review of GMP production batch records, review of testing data, approval of certificate of analyses, release of product, etc.Quality Control - Oversee and direction to Quality Control staff in the execution of raw materials testing, in-process testing, final product and stability testing. Materials Management - Leads this department to author raw material specifications, sourcing of raw materials, tracking of shipments, inventory management, cycle counts, shipment of product world-wide.GMP Facilities - Manages maintenance and repairs of GMP facilities including manufacturing cleanrooms and GMP utilities. Design and construction management of GMP facility expansions.GMP Manufacturing - Provides Quality direction to BioDuro's Manufacturing Department. Review and approval of production batch records and deviations. Well-planned improvements to Quality Systems directing GMP manufacturing operations. GMP Equipment and Utilities - Provides technical and Quality input on validations, calibrations, inspections, and maintenance of all GMP equipment and utilities.

PHARMACEUTICAL & BIOTECHInterfacing with clients on a daily basis to assess their needs, developing clear and transparent project proposals, working with external contractors and manufacturing service providers to ensure projects move forward, and completing tasks on time.Design and implementation of phase-specific Quality Systems to govern raw material ordering/receiving and qualification/release, non-conforming material investigations, manufacturing controls, product testing and release, product failure investigations, product shipping procedures, management/qualification of external contractors and manufacturing/testing service providers, complaint and CAPA systems, and Quality Manuals.Quality Assurance leadership for validation and licensing of aseptic biologics manufacturing facilities. Management and coordination of all contractors for the facility validations including HVAC, WFI and USP purified water systems, autoclaves, bioreactors, clean steam generators, vial/glass washer, biological safety cabinets, electronic security systems, refrigerators/freezers,and incubators.Collaborative trouble shooting of GMP Utility testing results not meeting specifications. Global auditing of GMP manufacturers and laboratories for U.S. FDA and European Commission compliance.Hands-on experience providing QA leadership on manufacturing campaigns for small molecules, sterile injectable peptides, and sterile protein based biologics.Management of Quality Control functions including approval of testing procedures, QC processes, and validation of bioanalytical assays. Sourcing and supervising contact product release and stability testing. Evaluating the cost/benefits of performing testing in-house vs use of external vendors.TOBACCO INDUSTRY & E-CIGARETTES: Auditing of suppliers of raw materials/ingredients, cartons/packaging/printing, waxes, flavorings, contract manufacturers, service providers, etc.

Senior Leadership of Quality Departments - creating, implementing, and maintaining robust Quality Systems designed to meet the evolving needs of pre-clinical, early and late stage product development.Created and managed the Quality Control Department - reviewing and approving all QC product procedures, environmental monitoring, sterile gowning qualification, WFI, RODI, gas systems sampling and testing, drug substance and drug product stability, and the raw material testing program. Managed outsourcing of testing to ensure high quality testing results. Review and approval of product-specific analytical and bio-analytical testing procedures and method qualification protocols, reports and data.Supervision of QC and Environmental Monitoring employees and sourced/purchased all of the Quality Control and environmental monitoring equipment. Created and Managed the Quality Assurance Department – Created, implemented, and maintain all La Jolla Biologics Quality systems including document control, GMP equipment systems, calibration and validation programs, CAPA, out of specification and out of tolerance SOPs, complaint systems, and internal/external audit procedures. Review/approval of draft production batch records and executed batch records for Bio-Similar products.Directly responsible for the management of the validation of a 55,000 square foot GMP manufacturing and testing facility. Validated utilities include RODI, clean steam, CO2, O2, and CCA gas systems, HVAC, autoclaves, and WFI systems. Review/approval of all validation protocols and reports/data. Proven success managing service vendors used for equipment start-up, maintenance, repair, and testing of facility utilities, lab equipment, and IT network and phone systems.Coordinate the installation, validation, and implementation of a compliant temperature/humidity monitoring/alarm system for all GMP clean rooms, incubators, refrigerators, warm-rooms, and freezers.

Successfully lead-hosted a six-day FDA inspection of Pharmatek for the PAI for two client pharmaceutical products.Senior management supervision of 14 successful European QP inspections of Pharmatek's manufacturing and laboratory facilities.Senior management supervision for all client audits of the Pharmatek facility (40 to 60 audits per year).Design, construction management, validation, and licensing of a 16,000 square foot facility for the laboratory handling and GMP manufacturing (Class 100,000 ISO 8) of cytotoxic and highly potent solid oral dosage forms.Design, construction management, validation, and licensing of a 34,000 square foot facility for the laboratory handling and GMP manufacturing (Class 100,000 ISO 8) of non-cytotoxic and non-highly potent solid oral dosage forms.Successfully worked with Pharmatek's finance and accounting departments and general contractors to keep construction projects within budgets and completed on time.Developed, implemented, and managed the Control Banding program for all new drug including cytotoxic and highly potent compounds.Developed, implemented, and managed Pharmatek's Employee Health and Safety program in association with representation from the manufacturing, laboratory, and human resources department.Point of contact within QA to resolve technical challenges in the analytical labs and for all facility related non-conformances.Supervise 9 Quality Assurance staff members including document control and QA supervisors/managers providing support for the analytical and manufacturing departments.Trained QA supervisors/managers to developed career paths and goal setting for their employees to meet the needs of the company as well as the career aspirations of employees.Founding Member of Pharmatek Executive Management Team aimed at company strategic planning and employee development.

Design, construction management, validation and licensing of two Class 100,000 (ISO 8) manufacturing suites and support areas (Pharmatek's Oberlin Drive facility) for use in GMP manufacturing of solid oral dosage forms.Authored Pharmatek's Facility and Validation Master Plans.Provide Quality Assurance consulting services to Pharmatek clients for phase appropriate GMP compliance.Created, implemented and managed all of Pharmatek Quality Systems. Perform internal audits of Pharmatek compliance systems and conduct external vendor audits.Host all Pharmatek client audits and inspections.Review and approve all Pharmatek manufacturing batch records pre and post execution.Review and approve all IQ/OQ/PQ and stability chamber validations pre and post execution for GMP/GLP laboratory equipment.Primary contact for the scheduling of maintenance and calibration of GMP/GLP equipment.Create and implement Pharmatek GLP program.Review and approve laboratory testing data and reports.Ensure that out of specification results are fully investigated and corrective actions are justified and in compliance with cGMPs.Manage all aspects of document control.Conduct GMP/GLP and SOP training for Pharmatek employees.

Performed all external audits for Corvas including vendors used for metrology, analytical testing, stability storage, bulk drug manufacturing, final drug product fill and finish sites, product label and packaging operations, and clinical supply distribution.Reviewed and approved all clinical packaging label proofs and final labels, randomization codes, packaging configurations, and packaging validations performed by external vendors.Performed periodic internal audits of Quality Control and Assay Services laboratories, Document Control, and Quality Assurance.Supervised all aspects of internal document control and regulatory/quality assurance consultants contracted by Corvas.Reviewed and approved all GMP instrument and method validations pre and post execution.Ensured that out of specification results were fully investigated and corrective actions were justified and in compliance with cGMPs.Reviewed and approved all data generated by the Quality Control and Assay Services departments.Conducted GMP/GLP and SOP training to members of product development and upper management.

Analytical Method Development

Assisted in the development of reversed-phase and strong cation exchange HPLC assays.Integration and statistical analysis of data.

Method validation and statistical analysis of data.Co-authored technical reports and protocols.Conducted HPLC assays.

Neuroimaging and analysis of histological data.Animal surgery, histology, and animal behavior testing