Description
Summary of Qualifications FDA audit experience Visionary leader/ mentor Profit growth perspective Cost Reduction Initiator Specialized expertise in Aseptic/ Sterile production cGMP and Regulatory guidance Managed Solid Dose Operations Code of Federal Regulations for ISO Standards Plant Startup Operations International Manufacturing Experience EH&S Incident Commander Lean manufacturing/ Six sigma Summary of Accomplishments: Wrote and conducted Manufacturing Technical Investigations, based on deviations, implemented corrective actions Wrote and revised Standard Operating Procedures Identified equipment validation discrepancies Addressed issues with nonconforming FDA/ GMPs requirements Conducted follow-up on CAPA Provided daily technical support and leadership in advanced troubleshooting that led to a safely environmentally sound facility managed to its optimum capability. Ensured effective and current job procedures existed for work done in the plant. Developed corrective actions to improve manufacturing operations. Worked with Supervisors to achieve all plant/site/business goals including EH &S, Reliability, Asset Capability, Cost, Quality, Improvements and Six Sigma. Ensured Most Effective Technology (MET) and specific operating discipline requirements are in place. Jan/ 2012 - June/ 2012, Manufacturing Manager, Avrio Biopharma (CMO), Irvine, California A privately owned company specializing in aseptic filling, formulation development, process validation, lyophilization Managed a team of twelve technicians and two supervisors supporting activities related to aseptic filling processing this included Clean Room Management, Autoclave Operations and Lyophilization Summary of Accomplishments: * Accomplished the validation of a new sterile filling suite which included classifying all room within the ISO 5 sterile filling suite * Validated a new filling machine which included the, commissioning, site acceptance test and media fills * Trained and certified all operators including myself on aseptic gowning * Developed and wrote the batch record for all clients * Developed new cleaning procedures for the maintenance of the clean room facility Summary of Accomplishments: * Accomplished the commissioning and startup of a new solid dose packaging line on second shift * Exceeded the production plan in each of the three years under my management. * Annually received the company's "Values of Work Award" based on my contribution in teamwork, excellence, accountability and FDA readiness * Co-managed a $10 million operating budget, meeting the corporate guideline target of 3% reduction * Launched three new solid dose products and one parenteral product * Worked with 3rd party for the development of the filling process of 3 phase II clinical products. * Developed the clean room management program to address all FDA issues with input for the cleaning efficacy studies for all three facilities * Developed the procedure for product containment of a sensitizer within the facility developed the conversion process by which we converted from manufacturing a cytotoxic product to sensitizer * Annually implemented over 100K in cost reductions working collaboratively with external vendors. * Monitor all manufacturing processes to ensure compliance with FDA regulations. * Responsible for all deviations within the process, conducted investigations and implemented corrective action. * Responsible for the consignment room inventory working with a VWR an external vendor client Aug/ 2003 / Sep 2006, Director of Manufacturing, DFB Biotech of Curacao Netherlands Antilles DFB (Dorman, Fike & Burnett) is a fully integrated specialty pharmaceutical company. The Curacao facility develops a collageanse enzyme used in conjunction with making a Santyl ointment used to treat second and third degree burn victims. As the Site Director, managed a team of 30 employees in the Manufacturing, Maintenance, Quality, Purchasing and Validation departments. Was the primary point of contact for all FDA inspections and regulatory audits. Elected to the board of Directors for the company and was the focal liaison point for the Dutch government. Summary of Accomplishments: * Increased company's productivity release rate from 40% to 70% within a 1 year timeframe. This led to the company increasing profitability significantly and far exceeding any past performances. Managed a staff of 15 technicians * Developed and implemented plans and schedules to address all deficiencies noted in prior FDA audit (2003). * Executed a comprehensive cGMP evaluation of all manufacturing equipment and correlated them to engineering programs in preparation for a scheduled FDA audit * Participated in two successful FDA follow up inspections by answering all technical concerns about the operation, leading to the removal of all regulatory restrictions * Developed the yearly manufacturing projections to meet sales requirements made adjustments for the latest estimates based on customer demand Jan/ 2002 - Aug 2003, Manufacturing Manager, Tyco Healthcare, Raleigh, North Carolina A global, $10B healthcare leader, focusing on the manufacturing of imaging solutions in both the sterile syringe and bottle IV delivery systems Summary of Accomplishments: Managed a two shift operation consisting of three line supervisors, one process engineer, two trainers and forty eight Team members Provided guidance to all subordinates in the areas of manufacturing, cGMP's and FDA regulatory guidance Led the department in labor and material reduction and reduced operator deviations by 70% Maintained a budget of over $1 million dollars Jan/ 2000 / Sept 2001, Manager of Aseptic/ Sterile Filling, Packaging and Maintenance, Hoffmann La Roche, Totowa, NJ A Fortune 100 Switzerland/New Jersey based (solid dose, sterile filling oral base) pharmaceutical company. Summary of Accomplishments: * Managed a three shift operation consisting of both maintenance and production staff consisting of three lines * Supervisors each supervising 10 personnel and a nine team member maintenance Implemented an automated filter integrity tester Maintained the #1 rated factories from a labor performance and customer service perspective Managed a budget over 18 million dollars Managed the operations for the liquids/ oral dosage department Cross training experience in encapsulation and granulation operations * Jan/ 1997 / Dec 1999 Manager of Manufacturing, Virally Inactive Technologies, Melville, NY, Start-up facility which used plasma from the blood center and virally inactivated the product for use for transfusions. Summary of Accomplishments: * Managed the department from facility start-up through final FDA approval, including staffing and writing departmental SOP. * Managed the Aseptic/ ISO 5 clean room operations Developed and maintained a budget of $4 million dollars Perform research on vendor pricing for the entire department for start-up operations focal point of all negotiations Worked with PLC's, Clean in Place (CIP), Steam Sterilization operating systems * Validated the following systems: Media fills and conformance lots, Aseptic /Sterile Filling Machine's installation * Completed the Performance Qualification, Steam Sterilization Cycles, Autoclave Cycle, Gowning * Developed Certification and Cleaning Procedure for the filling suite Cross trained in compounding, ultra filtration, and fractionation * Managed a 3 shift aseptic plasma filling operation consisting of 24 technicians and 3 team leaders Summary of Accomplishments: * Responsible for the direct supervision and development of a sterile filling operation consisting of 67 employees * Participated in the Malcolm Baldridge assessment for the company. Certified DDI Instructor Business Unit cost reduction Captain who exceeded the goal of $1.2 Million versus $1.6 million attained Head of committee consisting of eight peers that reduced product costs by 80%
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