Daniel R. Luedecking

abmgb1@r.postjobfree.com

818-***-****

Professional Summary:

Over 15 years of managerial and leadership experience various roles. Technical knowledge of manufacturing processes, cGMP’s, and organizational, and managerial, leadership skills. Committed to Quality, Core Values, Integrity, and being a team player. Participated in Process Improvement and Lean Manufacturing initiatives.

QUALIFICATIONS

• SAP • Lean Initiatives • Aseptic Operations

• Project Management • Change Management • Coaching

WORK EXPERIENCE

Best Formulations Rowland Heights, CA 2013 – 2014

Operations Manager

• Managed 8 direct reports and 150+ indirect reports.

• Managed multiple capital projects.

• Ensured production was balanced with planning, packaging, and customer timelines.

• Collaborated with cross-functional and support teams.

• Managed all manufacturing operations, Warehouse, and Maintenance teams.

• Implemented a recognition program in order to achieve higher morale with the production staff.

• Ensured a safe working environment in the facility by managing the EH&S program.

• Ensured that all production activities were accurately described in written procedures, and that these procedures met with cGMP, FDA, and Kosher requirements.

• Reduced batch record errors by 30%.

• Increased yields by 5% on some products.

• Delivered results by utilizing KPI’s (Safety, Delivery, Quality & people).

PHARMAVITE San Fernando, CA 2010 - 2013

Operations Supervisor

• Ensured that all production activities were accurately described in written procedures, and that these procedures met with cGMP and FDA requirements.

• Manage a Compounding, Gelatin manufacturing, Encapsulation, Tray drying, and Inspection team within the Soft Gel Department.

• Ensured that all production schedules were met. Communicated and coordinated priorities with Production Planning.

• Communicated with the Maintenance department regarding repair or preventative maintenance of machinery as required.

• Ensured a safe workplace and that all job activities were performed in a safe manner by utilizing the BBS Program.

• Administered disciplinary action, and provided coaching and counseling to improve the performance and morale of the manufacturing department.

• Delivered results by utilizing KPI’s (Safety, Delivery, Quality & people).

• Reviewed and approved performance reviews and objective for non-exempt employees.

• Delivered results by utilizing Key Performance Indicators (KPI).

• Decreased major and minor change over times by 50%.

• Decreased re-works by 40% with an AQL inspection process.

• Implemented new drip pans for the encapsulation machines to prevent hot gelatin from entering the machine and damaging vital components, which decreased downtime.

• Implemented new stainless steel vacuum wands for the gelatin melters to prevent break down of the rubber tubing.

• Performed scheduling changes when needed to minimize changeovers.

Amgen Thousand Oaks, CA 2005 - 2009

Manufacturing Manager

• Conducted performance reviews and set objectives for employees.

• Ensured that all production activities were accurately described in written procedures, and that these procedures met with cGMP and FDA requirements.

• Ensured that all production schedules were met. Communicated and coordinated priorities with Production Planning.

• Delivered results by utilizing KPI’s (Safety, Delivery, Quality & people).

• Communicated with the Maintenance department regarding repair or preventative maintenance of machinery as required.

• Directed personnel to complete and review all compounding and sterilization batch record documentation. Performed investigations and completion of process variance reports.

• Managed manufacturing of filling, component prep, compounding, and packaging product releases to meet all regulatory and commercial needs.

• Worked cross-functional teams as necessary to support new product implementation (NPI).

• Led projects on the implementation of new components and equipment for the filling and packaging operations.

• Promoted continuous improvement in efficiency, quality and safety through team activities, SOP updates, and work order generation.

• Directed the activities and resolution of complex issues and potential problems related to filling and packaging operations. Ensured the proper maintenance of aseptic regulatory standards for aseptic manufacturing processes and packaging processes.

• Worked closely with the Quality department to assure systems and processes meet regulatory compliance.

• Create, track, and manage project budget, timelines, tasks, responsibilities and activities to meet client and internal expectations. Monitor and report on departmental Key Performance Indicators (metrics).

Pfizer Portage, MI 2000 - 2005

Manufacturing Supervisor

• Led, developed, and motivated manufacturing operators on 3 shifts. Managed 2 supervisors per shift plus hourly staff.

• Delivered results by utilizing KPI’s (Safety, Delivery, Quality & people).

• Formulated and filtered sterile solutions and suspensions for injection in humans and animals. Managed the production support team for a sterile plant to accommodate 13 sterile filling lines. Hands-on knowledge of aseptic vial and syringe filling as well as lyophilization (freeze drying).

• Hands-on knowledge of Commercial manufacturing and management experience in a manufacturing environment.

• Managed, conducted and coordinated failure, incident/deviation and discrepancy investigations.

• Conducted performance reviews and set objectives for manufacturing supervisors. Reviewed and approved performance reviews and objectives for non-exempt employees.

• Ensured that all production schedules were met. Communicated and coordinated priorities with Production Planning.

• Communicated with the Maintenance department regarding repair or preventative maintenance of machinery as required.

• Ensured that all production activities were accurately described in written procedures, and that these procedures met with cGMP and FDA requirements.

• Responsible for aseptic clean room addition of suspended active drug components.

• Ensured a perfectly sterile product for our customers every time every day.

• Member of the Sterile Manufacturing Safety Committee.

• Maintained training on new employees with sterile manufacturing procedures, aseptic processing techniques, and sterile filling procedures.

• Demonstrated Leadership capability by ensuring First Time Quality, attention to Safety, and maintaining a clean and organized work area.

Schneider National Portage, MI 1999 - 2000

Operations Manager

Managed truck drivers out of an operations center.

United States Navy San Diego, CA 1985 - 1998

Shop Supervisor, Project Manager

Managed multiple construction projects in the United States and in multiple countries around the world. Welding, fabrication, and sheet metal was my field of expertise.

EDUCATION

Masters Degree, Business and Technology Management.

2005 – 2008 Coleman College San Diego, Ca

Bachelors Degree, Computer Science,

1995 - 1998 Coleman College San Diego, Ca

Contact this candidate