Experience

DPT Laboratories

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Director Quality Systems & Regulatory Compliance

  • Nov 2021 - Present

• Sr. Manager Regulatory Compliance & Investigations

  • Sep 2020 - Nov 2021

  •Report monthly site metrics to Viatris Corporate Quality Council •Create site policies and procedures to align with new site responsibilities for Quality Council and critical investigation management •Manage Regulatory &Compliance staff of 5 personnel •Oversee site self-inspections •Manage site annual Global Operations audits •Supported and submitted FDA documentation for FORM 4003 audit •Created virtual audit program and support customer site audits virtually due to… Show more •Report monthly site metrics to Viatris Corporate Quality Council •Create site policies and procedures to align with new site responsibilities for Quality Council and critical investigation management •Manage Regulatory &Compliance staff of 5 personnel •Oversee site self-inspections •Manage site annual Global Operations audits •Supported and submitted FDA documentation for FORM 4003 audit •Created virtual audit program and support customer site audits virtually due to COVID •Perform final approval for site critical investigations

• Senior QA Manager

  • May 2018 - Sep 2020

  • In addition to Quality Assurance Manager duties: - Aligned site policy and procedures with Mylan Corporate Quality - Facilitated continuous improvement through Daily Management System (DMS) for Quality team - Reported monthly KPI’s for Quality to senior management - Responsible for escalation of critical quality events to Mylan Corporate Quality - Facilitated timely closure of FAR investigations through collaboration with the market authorized holder

• QA Manager

  • Oct 2013 - May 2018

  •Managed Quality Assurance staff of 18 personnel for Contract Development Manufacturing Organization (CDMO) accounts •Primary contact for CDMO customers for quality investigations, complaints and review/release of products •Responsible for Plant Quality activities, to include Acceptance Quality Limit (AQL) sampling and Batch Record review and release for R&D and Commercial Production •Responsible for managing and approving CDMO product deviations and complaints •Managed the Root… Show more •Managed Quality Assurance staff of 18 personnel for Contract Development Manufacturing Organization (CDMO) accounts •Primary contact for CDMO customers for quality investigations, complaints and review/release of products •Responsible for Plant Quality activities, to include Acceptance Quality Limit (AQL) sampling and Batch Record review and release for R&D and Commercial Production •Responsible for managing and approving CDMO product deviations and complaints •Managed the Root Cause Analysis (RCA) process for major and critical deviations and complaints •Revise and/or approve Standard Operation Procedures (SOPs) to ensure compliance and current industry practices •Lead in War Room for Health Authority general and pre-approval inspections: EMA, FDA, and MHRA •Lead QA host for FDA agent during general GMP inspection •Identified CAPA through RCA and performed risk assessments prior to continuing production •Completed Annual Quality Systems Review Reports •Managed departmental budget •Monitored metrics for time management of CAPA, deviations and complaints to ensure deadlines are met •Initiated Continuous Improvement for Investigation process improvements and Plant Quality •Supported CDMO customer audits for Quality Assurance

• R&D Senior Research Scientist

  • Apr 2011 - Oct 2013

  •Technical Liaison between Customers, Quality, Operations, Engineering and R&D for all aspects of commercial production •Provided technical support for commercial investigations and deviations •Identified and improved procedures for compliance with cGMP and regulatory guidelines •Prepared technical reports and documents for support of product release •Improved current manufacturing processes to support lean manufacturing •Mentored and developed internal talent

• R&D Formulations Group Leader

  • Mar 2008 - Apr 2011

  •Matrix managed a group of 13 scientists with two other Group Leaders •Managed projects for a group of 3 scientists and 1 technologist •Ensured that lab personnel remained current and trained on SOPs and cGMP practices •Reviewed and approved project protocols. Ensured estimated labor requirements were current and sufficient to complete project scope •Ensured scope of project was within regulatory requirements •Provided technical expertise and guidance to customers and internal… Show more •Matrix managed a group of 13 scientists with two other Group Leaders •Managed projects for a group of 3 scientists and 1 technologist •Ensured that lab personnel remained current and trained on SOPs and cGMP practices •Reviewed and approved project protocols. Ensured estimated labor requirements were current and sufficient to complete project scope •Ensured scope of project was within regulatory requirements •Provided technical expertise and guidance to customers and internal departments •Mentored and promoted the technical and professional development of direct reports •Managed the formulation development efforts and scale up time lines of projects •Established and implemented systems for technology transfer and scale up •Reviewed and approved compounding batch records and process instructions for batch manufacturing at cGMP facility

• Senior Scientist, Process Development

  • Apr 2004 - Mar 2008

  •Developed R&D, validation, and commercial manufacturing processes for pharmaceutical creams, gels, lotions, suspensions, foams, solutions and ointments •Experienced with hot melt extrusion technology •Provided technical advice on investigations for commercial products •Developed manufacturing procedures from laboratory bench size (1-2 kg), to clinical supply batch size (30-200 kg) to commercial production batch size (200 – 20,000 kg) •Determined critical process parameters prior to… Show more •Developed R&D, validation, and commercial manufacturing processes for pharmaceutical creams, gels, lotions, suspensions, foams, solutions and ointments •Experienced with hot melt extrusion technology •Provided technical advice on investigations for commercial products •Developed manufacturing procedures from laboratory bench size (1-2 kg), to clinical supply batch size (30-200 kg) to commercial production batch size (200 – 20,000 kg) •Determined critical process parameters prior to validation of commercial manufacturing processes •Supported Quality investigations for product manufacturing deviations •Prepared compounding batch records for R&D, process development and scale-up •Prepared product change controls, critical process parameters and flow diagrams •Supervised 4 Technologists



L'Oréal

• France
• Personal Care Product Manufacturing
• 700 & Above Employee

• R&D Chemist

  • Jul 2002 - Mar 2004

  •Developed Treatment and Hygiene products for Kiehl’s, Ralph Lauren and Redken •Formulated OTC products (anti-acne, sunscreens and anti-perspirants) •Formulated Aerosol products for Ralph Lauren •Reformulated numerous Kiehl’s products to remove animal derived raw materials •Developed best-selling Ultimate Strength Hand Salve for Kiehl’s •Involved in process development for production manufacturing at various facilities •Responsible for the management and training of three… Show more •Developed Treatment and Hygiene products for Kiehl’s, Ralph Lauren and Redken •Formulated OTC products (anti-acne, sunscreens and anti-perspirants) •Formulated Aerosol products for Ralph Lauren •Reformulated numerous Kiehl’s products to remove animal derived raw materials •Developed best-selling Ultimate Strength Hand Salve for Kiehl’s •Involved in process development for production manufacturing at various facilities •Responsible for the management and training of three junior chemists Show less •Developed Treatment and Hygiene products for Kiehl’s, Ralph Lauren and Redken •Formulated OTC products (anti-acne, sunscreens and anti-perspirants) •Formulated Aerosol products for Ralph Lauren •Reformulated numerous Kiehl’s products to remove animal derived raw materials •Developed best-selling Ultimate Strength Hand Salve for Kiehl’s •Involved in process development for production manufacturing at various facilities •Responsible for the management and training of three… Show more •Developed Treatment and Hygiene products for Kiehl’s, Ralph Lauren and Redken •Formulated OTC products (anti-acne, sunscreens and anti-perspirants) •Formulated Aerosol products for Ralph Lauren •Reformulated numerous Kiehl’s products to remove animal derived raw materials •Developed best-selling Ultimate Strength Hand Salve for Kiehl’s •Involved in process development for production manufacturing at various facilities •Responsible for the management and training of three junior chemists Show less



The Estée Lauder Companies Inc.

• United States
• Personal Care Product Manufacturing
• 700 & Above Employee

• R&D Chemist

  • Apr 2000 - Jul 2002

  •Developed water/silicone, water/oil and oil/water emulsions for new product launches •Researched Rosacea and hyper-pigmentation treatments •Reformulated surfactant and polymer gels for existing products •Color matched products to standard •Worked with Marketing to develop products for Skin Supplies for Men line

• Biological Research Scientist

  • Feb 1999 - Apr 2000

  •Researched and developed potential biologically active raw materials for cosmetic products •Refined crude plant materials into commercially feasible raw materials for use in Estee Lauder Treatment products •Ran HPLC, flash column chromatography, TLC, soxhlet and solvent partitioning •Collaborated with vendors and outside researchers to establish refined materials and new technologies