Experience

Pegasus Laboratories, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Operations Manager

  • Oct 2020 - Present



Lannett Pharmaceuticals

• Manufacturing Supervisor

  • Sep 2014 - Nov 2020

  Supervise 15 - 20 Operators per shift; collaborate with Planning Department to facilitate successful completion of all production requirements, maintain safety, environmental, and cGMP compliance to assure production standards. Authored Investigation Reports for Process Deviations and Root Cause Trained Operators and maintain 100% SOP training completion.I also manage the Compression (Fette, and Korsh press), Glatt Fluid Bed, Vector Flo Coater, Vector Pan Coating, Granulation, Sweco Sieving, Milling & Blending. Part of Process Improvement team assigned with the responsibility of establishing standardized processing times and to reduce cost per thousand.



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Production Maintenance Supervisor

  • Aug 2009 - Oct 2014

  Perform ongoing Standard Operating Procedure reviews to ensure accurate and compliant Aseptic Production Facility standards and operation.Review AMMS (Advance Maintenance Management System) records in real time to ensure compliance and conformance.Author Investigations utilizing the Trackwise System. Author Protocols utilizing the Trackwise System.Timely and accurate execution of all Preventative Maintenance, Break Downs, and Corrective work orders on the following equipment: Sterile Filling Lines, IMA Vial Washers, Vial Sealers, De-pyrogenating Tunnels, & Inspection/ Labeling/Packaging Lines.Successfully executed 5 S + 1 methodology project.Represented the department as the subject matter expert for all cGMP audits, and change control activities. Reduced machine down time by analyzing corrective work order history and developing preventative maintenance activities based on the results.Reduced machine parts replacement cost by sourcing them from local vendors.Improved machine efficiency by utilizing the change control process to implement process improvements on the equipment Selected to be a member of a small team retained to complete the closure of Ben Venue Laboratories Good Engineering Practices (GEP Decommissioning).

• Production Maintenance Supervisor

  • Aug 2009 - Sep 2014

  Supervise and Manage Mechanics in all aspects of Production Maintenance, ensure compliance with all Gowning Procedures for Aseptic Manufacturing Facility, as well as coordinate with the Production Departments to meet ongoing requirements of Sterile Filling Department. Additionally, establish both group and individual performance and production goals, as well as perform Performance Appraisals for Mechanics.



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• Production Supervisor

  • May 2005 - Aug 2009

  Supervised 12-14 Operators per shift; collaborated with Planning Department to facilitate successful completion of all production requirements, maintained safety, environmental, and cGMP compliance to assure production standards. Authored Investigation Reports for Process Deviations and Root Cause Analysis, as well as implemented several LEAN processes in production. Trained Operators and maintained 100% SOP training completion.I also managed the Compression & Blending (Fette, and Killian press), Glatt Fluid Bed, Niro Fluid Bed, Sweco, Ovens, and Pan coating operations.

• Production Supervisor

  • May 2005 - Aug 2009

  Supervised a staff of 15 Production Operators.Assisted with the Validating of the cleaning procedures for several key manufacturing processes.Knowledge of SAP system.Generated daily down time reports.Performed weekly one on one meetings.Performed yearly Performance Reviews.Assisted with setting departmental yearly goals and objectives.Achieved 100% on time shipment (2007 - 2009).Worked with the planning department to determine weekly production schedule.Wrote investigation reports for process and operational deviations.Improved manufacturing by doubling the production output/yield on several key products.Initiated Change Controls for equipment and batch record changes.Maintained safe working environment by performing weekly cross functional safety audits.Updated/reviewed Standard Operating Procedures.Executed 5S (six sigma) methodology on several key processes.Knowledge of Lean Six Sigma Manufacturing.Assisted in initiated several Lean Methodology systems.Team member of several Kaizen events.Organized a Kanban system for WIP materials.Perform Quality dispositions for Processing Rooms, Equipment and Product.Extensive operational knowledge of solid dosage; using (Fluid Bed Coating, Compression, Blending, Milling, Pan coating, Granulation) - Glatt, Niro, Fete, Fitzmil, Comil.



Andrx Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manufacturing Specialist/Group Leader

  • Jan 2000 - May 2005

  Supervised and scheduled Operators to meet production requirements, as well as trained Operators for specific equipment and processes. Ensured all Prescription Drug Manufacturing Processes followed corporate Standard Operating Procedures, as well as cGMP standards and processes. Trained and operated Compression machinery using the Fette and Killian press. Trained and operated the Glatt Fluid Bed, Niro Fluid Bed, Sweco, and Ovens.Knowledge and understanding of cGMP.Proficient in Fluid Bed Coating using Glatt (GPCG 60, 200, and 300).Knowledge of Compression using the Kilian, Hata Press, and Fete Press.Worked along side Technical Services during Product Scale up Projects.Updated/ Revised Standard Operating Procedures.Updated/Revised Master Batch Records.Worked collaboratively with Material Disposition, Quality Assurance, Research & Development and Logistics.Attended Kepner Tregoe training on Root Cause Analysis.Finalized the production scheduled with the shift Supervisor and Manager.Monitor cycle times for processed batches and production down time.Understand the operational capabilities of the machinery and can execute Preventative Maintenance if necessary.Supervised shift in the absences of the Production Supervisor.



Oscar Francois Ltd ( Pharmaceutical & Costmetic Distributor)

• Customs Clerk

  • Jan 1995 - Aug 2000



Francois Ltd ( Pharmaceutical & Cosmetic Distributor)

• Customs Clerk

  • Jan 1995 - Jan 2000

  Processes all required documentation required for Importation and Exportation of Pharmaceutical products.Liaise with Customs & Excise and Food & Drugs department on a daily basis.Answer queries on shipping documentations.Filed for permits to import human and animal vaccines with the Trade and Industry and Ministry of Agriculture departments.Cleared pharmaceutical products from the Air Port.Accreditation Trained by Glatt Air Techniques in Fluid Bed Coating. Attended Train the Trainer course.Trained by Micro Motion Technologies on the Micro Motion sensor system.