Experience

Avadel Pharmaceuticals plc

• Biotechnology Research
• 100 - 200 Employee

• Director Of Technical Operations

  • Oct 2018 - Present



Tergus Pharma

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Director of Technical Operations and Quality Control

  • Apr 2018 - Oct 2018

  Serve as site leadership team member for manufacturing, warehouse and quality control functions. Manage a team of manufacturing, quality control and method validation professionals (6 Direct/12 Total). Responsible for the manufacture and testing of clinical trial materials in a CRO environment for topical pharmaceutical products. Responsible for customer communications to ensure project timing and customer expectations are managed effectively. Serve as site leadership team member for manufacturing, warehouse and quality control functions. Manage a team of manufacturing, quality control and method validation professionals (6 Direct/12 Total). Responsible for the manufacture and testing of clinical trial materials in a CRO environment for topical pharmaceutical products. Responsible for customer communications to ensure project timing and customer expectations are managed effectively.



Ei - A Pharmaceutical SolutionWorks™

• Kannapolis, North Carolina

• Site Director of Quality and Technical Operations

  • Aug 2017 - Feb 2018

  Serve as site leadership team member for quality and technical functions. Manage a team of quality and technical professionals (6 Direct/30+ Total). Responsible for quality oversite, documentation control/modification, quality systems (CAPA/External Audit Program/Deviation Management) and product release for cream, liquid and gel products (Rx, OTC and cosmetic). Ensure effective technology transfer and validation for a continuous pipeline of 20 new products within a CDMO environment. Support customers with CMC filing and FDA deficiency responses to ensure timely approval of new products. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Operations Support Manager

  • Feb 2016 - Aug 2017

  Serve as site leadership team member for operations support function with budgetary responsibilities. Manage a team of professionals (6 Direct/15-18 Total) to support the operations and packaging teams in the areas of deviation investigation management, CAPA initiation/completion, documentation support (SOP and batch record creation/modification) and OEE analysis/improvement. Support the product release process by identifying potential release issues early in the process to ensure that quick communication can be initiated to the supply and quality teams and to implement action plans to mitigate issues. Show less



Virbac

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technology Transfer Manager

  • Nov 2015 - Feb 2016

  Manage a team of technical professionals (7-8) to complete technical transfer projects with the goal of bringing products back to market after a warning letter. Define process critical quality attributes, critical material attributes and critical process parameters. Write process/product control documents to demonstrate process robustness. Manage a team of technical professionals (7-8) to complete technical transfer projects with the goal of bringing products back to market after a warning letter. Define process critical quality attributes, critical material attributes and critical process parameters. Write process/product control documents to demonstrate process robustness.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technical Services Remediation Team Lead

  • Oct 2014 - Nov 2015

  Manage a team of technical professionals (2-3) to complete various process improvement projects (product and equipment focused) to improve product quality and to increase process control as part of a self-initiated site remediation effort. Implement and maintain a product control strategy/PLM program (where no program was previously in place) for multiple solid dosage OTC products to improve product consistency with an overall goal of changing the site continuous improvement process from a reactive to a proactive method. Show less



Conagra Brands

• United States
• Food and Beverage Services
• 700 & Above Employee

• Principal Engineer

  • Nov 2010 - Sep 2014

  Support 24 production plants with process improvement efforts while engaging/leading plant personnel in various process improvement efforts without having direct supervisory responsibility. Lead process improvement efforts (variation reduction, mean shift and root cause analysis) for multiple private label food products with a strong emphasis on extruded corn, baked goods and emulsion products. Train plant personnel on the use of root cause, SPC and process improvement tools to enhance the site’s capability of performing RCA and to transfer knowledge across all sites as part of the company’s global training initiative. Show less



Patheon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Scientist

  • Jul 2010 - Nov 2010

  Work as the technical contact at a contract manufacturing facility for R&D products initiated by external customers (outside pharmaceutical companies). Assist in developing documentation and experimental designs for product scale-up and validation activities. Modified current fluid bed process to a multistage process to mitigate the product bed from seizing during the production process while reducing production time by a 33%. Work as the technical contact at a contract manufacturing facility for R&D products initiated by external customers (outside pharmaceutical companies). Assist in developing documentation and experimental designs for product scale-up and validation activities. Modified current fluid bed process to a multistage process to mitigate the product bed from seizing during the production process while reducing production time by a 33%.



KV Pharmaceutical

• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Process Development Scientist

  • Oct 2008 - May 2010

  Work as technical SME for multiple products (immediate and extended release) with a quality consultant group and cross functional team with the goal of bringing products back to market after a consent decree. Define process critical quality attributes, critical material attributes and critical process parameters and write QbD product historical assessments for immediate and extended release solid dosage products to demonstrate process control. Train all production and quality personnel on process/system changes to gain alignment and understanding prior to implementation. Write experimental protocols utilizing a DoE approach, final reports, technology transfer documentation and batch records for immediate and extended release solid dosage products. Show less



Mallinckrodt Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Research Engineer/Senior Research Chemist

  • Mar 1999 - Oct 2008

  Engineer: Work with a cross functional team to setup and commission a pilot plant for solid dosage pharmaceutical development and clinical batch manufacture. Work with project engineering to select equipment, to define user requirement specifications and to evaluate qualification documentation prior to equipment installation. Serve as the technical expert on a cross functional team in performing SAT/FAT equipment evaluations and IQ/OQ testing for processing/facility equipment. Write SOPs and other procedures for a GMP pilot plant for both research and clinical manufacturing. Formulation Chemist: Serve as SME for between 3-5 projects to support site’s pipeline of new ANDA controlled substance products. Design immediate and extended release solid dosage (capsule and tablet) and liquid (suspension) formulations in a GMP\DEA regulated environment from research to commercial scale. Write experimental/stability protocols and final reports utilizing a DoE approach for immediate and extended release solid dosage products to ensure product/process understanding prior to submission. Perform statistical analysis of all analytical results utilizing Minitab for report inclusion and to establish product specifications and process parameter processing ranges. Assist regulatory affairs in filing new ANDAs and preparing responses to product deficiency letters. Train site R&D personnel on the operation of pharmaceutical processing equipment (tablet presses, high shear granulators, fluid beds, etc). Serve as the primary site contact for the purchase and installation of new equipment when required. Show less



Multidata

• Applications Physicist

  • 1997 - 1999

  Install water phantom, RTD (Real Time Dosimetry) software/hardware and DSS (Dosimetry Software System) software/hardware for customers. Provide training on how to use software to generate a beam library for various linear accelerators and to setup and edit a radiation treatment plan for a patient. Install water phantom, RTD (Real Time Dosimetry) software/hardware and DSS (Dosimetry Software System) software/hardware for customers. Provide training on how to use software to generate a beam library for various linear accelerators and to setup and edit a radiation treatment plan for a patient.



Triad/SIUE

• Illinois

• Teacher

  • Apr 1996 - Jun 1997

  Teach middle school and secondary students in the areas of science an math. Teach middle school and secondary students in the areas of science an math.