Manufacturing Manager Injection Molding
Resume:
TIM MADDEN
***.*********@*****.***
SUMMARY
Operations/Maintenance Manager with expertise in manufacturing pharmaceutical LVP products and devices. Advanced skills in managing a broad range of manufacturing, maintenance, and process improvement activities in a 24/7 high volume environment. Facilitates and drives continuous improvement initiatives to optimize performance, eliminate waste, reduce cost, and expedite service. Success leading multiple projects of diverse scope and monetary value. Achieves consistent results within a participative, team orientated, and customer focused environment.
SKILLS and COMPETENCIES
Project Management: Operational Excellence, Supply Chain, Continuous Improvement, and Equipment/Facility/Process validation leadership experience
Quality & Regulatory Compliance: ISO 9001, ISO 13485, 21 CFR (Parts 11, 210, 211, & 820), Audits ( FDA, EU, PAI, and Customer), Quality Risk Management, Change Control, cGMP, Document Control, and CAPA
Plastics Processing: Film Extrusion, Compounding, Calendering, Injection Molding, Blow Molding, MIM, & LIM
Financial: Prepare budgets and forecasts, P&L responsibility, capital planning, inventory management
Batch Records and Procedures: Author, Audit, Review, and Enforce
Continuous Improvement: Lean, Six Sigma, OPEX, 5S, KPI achievement, and Kaizen
Equipment & Facility: Cleaning and Sanitization (CIP & SIP), WFI quality and compliance, clean room manufacturing, tribology
Safety: Zero Accidents, Root Cause & Preventative Action analysis, FMEA, PPE, and OSHA Regulations
Maintenance: International Council for Machinery Lubrication MLT I / MLA I, CMMS, TPM, Design for Success
PROFESSIONAL EXPERIENCE
Applied Medical Rancho Santa Margarita CA
Applied Medical is a global organization that develops, manufactures, and distributes medical devices.
Polymer Maintenance Manager March 2021 – Nov 2022
Managed a team of seven Mechanics who maintained 46 injection molding machines, two metal injection molding debinding and sintering systems, six thermoset rubber presses, four extrusion lines, one film slitter, and all ancillary equipment.
Installed three new injection molding machines
Installed new VFD controlled Liquid Injection Molding System
Retrofit two polymer injection molding machines to also process MIM
American Renolit, Commerce CA
A leading global specialist for high-quality plastic films, sheets, and other plastic products for medical and pharmaceutical applications, such as blood bags and infusion systems.
Maintenance Manager, Facilities and Production 2014 – Jan 2021
Maximize the availability, efficiency, and safety of assets at the lowest possible cost. Managed a team of ten maintenance employees who maintained equipment on eleven production lines as well as the facility. Actively participated in process improvement, capital equipment installation, and lean initiatives.
Installed new calender line to replace aged equipment and expand capacity.
Assumed responsibility for clean room and facilities cleaning Technicians.
ISO 13485 auditor, performed internal audits to ensure no observations were issued during customer audits.
Four years no “lost time” accidents while increasing production yields significantly.
B BRAUN Medical Inc., Irvine CA
Global provider of health care products, operates in 50 countries with sales of > $6 billion ($1 billion US). Irvine is the Center of Excellence for Large Volume Parental production.
Business Unit Manager, Weighing, Mixing, and Sterilization 2010 - 2014
Managed (WMS) operations including weighing raw materials (API), compounding solutions (13 filling lines), and steam sterilization of > 150 million Large Volume Parenteral containers. Directed Production Services which cleaned and sanitized the clean rooms, ancillary equipment, and performed WFI system sanitization. Utilized Lean principles and tools to develop and implement process improvement ideas which eliminated waste and optimized the performance of constraining operations.
Facilitated Sterilization Optimization kaizen which reduced sterilization load/unload time.
Completed new LVP solution qualification and validation studies; CIP/SIP cycles, clean/dirty/maximum hold times, swab/rinse sampling, and riboflavin studies.
Increased regulatory compliance and consolidated cleaning functions into the business units by redesigning the cleaning procedures/check sheets.
Completed the following Lean kaizens, New WMS shift configurations, WFI level loading, and Cascade Mixing.
Manufacturing Representative/Owner on the Automated Mixing Complex project. Involved with 3P design process, equipment specifications, procedure generation/approval, staffing, and validation.
Manufacturing Supervisor, PIC, Blow Molding, Injection Molding, and Glass 2006 - 2010
Supervised Plastic Irrigation Containers (PIC), Blow Molding, Injection Molding, and Glass business units with sales of 24.3 million units/$80 million. Responsible for annual operating plans and budgetary P&L. Clearly defined responsibilities and provided learning opportunities which condition team members to assume responsibility (clear direction/s, ample motivation, and supportive environment).
Managed the outsourcing of an additional ~ 4 million units of finished goods volume by qualifying/validating production equipment for contract manufacture.
Established and balanced production schedules to ensure correct product mix and optimal customer service level (metric, order service level of 95% and back orders below $250,000).
Protected core business by leading cross functional teams on sterilization label replacement and silicone carrier solvent projects.
Completed resin dryer relocation, vacuum pump centralization, automated vision system, and continuous improvement kaizens.
Managed $20 million A1 “Clinical Nutrition” program. Managed the R&D Lab to ensure registration batches were completed within project timeline, cost constraints, and equipment / process met regulatory requirements.
Manufacturing/Maintenance Supervisor, Film, Compounding, Blow Molding, and Injection Molding 2002 - 2006
Accountable for cost control, quality control, process improvement, training, maintenance, and employee relations issues for 60 employees. Introduced new plastics processes/products, and validated compliance with cGPMs, FDA, and OSHA regulations. Provided a strong technical base for leading investigations into manufacturing problems and the development of alternate solutions.
Installed new tri-layer cast film line to vertically integrate in-house manufacturing capacity which resulted in annualized savings of $2.5 million.
Installed a new compounding / pelletizing line which resulted in annualized cost savings of over $2 million.
Optimized manpower utilization, increased line efficiency, and provided job enrichment by cross-training employees from two separate lines.
Awarded "Certificate of Appreciation" for contributions leading to FDA approval of the DUPLEX drug delivery system (sales > $100 million).
EDUCATION
Bachelor of Arts, Business Administration
California State University, Fullerton
Vocational Degree, Electronics Technologist
Waukesha County Technical College
AFFILIATIONS / ASSOCIATIONS / MEMBERSHIPS
California Board of Pharmacy, Designated Representative (license number EXC 18732)
B BRAUN Safety Committee Member
Lean Basic certification, Lean Alliance
Six Sigma Yellow Belt certification, Go Lean Six Sigma
American Renolit ISO 13485 Internal Auditor
International Council for Machinery Lubrication certification; MLT I & MLA I
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