Operations Manager Medical Devices

Marty Pullin

OPERATIONS MANAGER

*** **** **. **********, ** 40391 386-***-**** *********@*****.***

Profile

21+ years of success with Medical Devices and Pharmaceutical companies.

Results include:

Functioned as change agent. Facility was scheduled to reduce operations from headcount of 200 associates to 40 associates. The facility now has 250 associates with record volume output and approximately $350 million dollars a year in revenue.

Developed and achieved budget goals of $26 million dollars for facility.

Drove production attainment from 85% to 95%+ with no additional capital expense.

Increase efficiency 10% by driving production scheduling to be in line with production asset utilization.

Eliminated cost of $450,000 with Kaizen event to reduce material movement.

Reduced customer complaints by 20% by using root cause analysis.

Drove Quality with BRRFT (Batch Record Right the First Time) from 60% to 90%+

Establish capital projects against $1.6 million dollar budget.

Lean Certification, Green Belt Certification.

EDUCATIONAL BACKGROUND

Sullivan University-Lexington, KY

Completed courses in Managerial Accounting, Corporate Finance, and Managerial Communication as part of an MBA program.

University of Kentucky-Lexington, KY

Bachelor of Business Administration.

SKILLS & EXPERTISE

Lean Manufacturing, Statistical Process Control, Equipment Operations, Six Sigma, Mistake Proofing, Microsoft Office Software, Kaizen Principles, Strategic Analysis, Value Stream Mapping, Kanban Systems, Project Management, Employee Empowerment.

PROFESSIONAL EXPERIENCE

Avantor Performance Materials, Inc. (350 Headcount on site)-Paris, KY June 2014 - Present

Pharmaceutical chemicals sub-division/packaging (blending, bottling, and packaging)

Operations Manager

Responsibilities and Accomplishments

Developed and Approved Capital expense projects.

Managing 4 Production departments (Drys and bottling) 7-day operation.

Managing Engineering and Maintenance departments.

Develop, maintain, and meet budget goals. ($350MM annual revenue)

Developed/Responsible for Key Performance Indexes. Safety (near misses), Quality (BRRFT), Delivery (OTIF), Production (hours/associate).

Lead and participated in several customer audits.

Evaluated and moved product lines from plant to plant.

Drive problem solving for customer complaints using root cause analysis tools.

Evaluated capacity to accommodate new business/product lines.

Developed budget and execute throughout the year.

Managed Kaizen event to improve Distribution department.

Managed Engineering and Maintenance Department.

Drive inventory control measures.

Managed PSM (Process Safety Management) activities.

Lead/Assist in Audits from FDA, DOT, DEA, EPA, and Homeland Security.

Managed validated cleanouts, pest control, and anti-product contamination programs.

Customer Focus (Meeting with Customers during audits and understanding their expectations).

Drove OTIF Delivery (On Time In Full) by aligning production with shipping requirements.

Weekly production scheduling to maximize efficiency of all assets increase by 10%.

Developed and led improvement teams to maximize asset utilization, increase constrained asset by 30%.

Reduced spending in Maintenance Department by 20% for replacement Filters.

No recordable Safety Incidents. TRIR >1.

Implemented Mini T program to maintain KPIs.

Coached extended leadership group to use root cause analysis to reduce customer complaints by 20%.

Implemented and Maintained Mentoring Program for entire facility. Three associates were selected and utilized on different improvement program.

Developed Performance Management system, which achieved increase in production attainment. (Stop light chart).

Developed Facility Polices as a member of the Site Leadership Team.

Provided coaching for department Supervisors.

Implemented Lean systems to increase production efficiency (Kaizen Event).

Led Kaizen event for Receiving Warehouse. (Manpower utilization and accountability)

Led Kaizen event for streamlining Procedures (Training for hourly associates)

Increased daily average throughput for individual associate in Drys department by 50%.

Implemented visual factory program (Communication Boards).

Managed department expenses relative to 24-million-dollar budget and deliver favorable results.

Completed HAZWOPER training.

Implemented a 6S program.

Enhanced procedures to ensure compliance with FDA regulations.

Catalent Pharma Solutions (250 headcount on site)-Winchester, KY December 2012- June 2014

Pharmaceuticals

Business Unit Leader (3 Direct reports, 40 Indirect reports)

Responsibilities and Accomplishments:

Completed training for Green Belt certification.

Spearheaded project so that 100% of associates are trained with updated Standard Operating Procedures through regular review process.

Delivered production results to meet the production schedule.

Schedule all associates time at work, vacation time, and overtime.

Developed goals for production.

Developed workforce by preparing individual associates for promotional opportunities.

Provided coaching on a consistent basis on the production floor to ensure 100% compliance with cGMP regulations.

Improved compliance with established SQDC (Safety, Quality, Delivery, and Cost) goals and ensure that production associates are aware of these goals and results via visual factory boards.

Delivered compliance with FDA regulations.

Covidien (500 headcount on site) – Deland, FL December 2005 – December 2012

Medical Device Company specializing in hypodermic needles.

Production Leader (2 Direct reports, 150 Indirect reports) January 2010 – December 2012

Focus Factory – Plastics Molding, Syringe assembly and packaging, Needle Assembly, and Cold Heading.

Responsibilities and Accomplishments:

Responsibilities/accomplishments same as listed under Production Superintendent.

Headed Multiple Kaizens (20+)

Implemented a Kaizen event to relocate raw material in department to reduce material movement. Reduction of indirect labor with a $450,000 a year savings.

Implemented Heijunka Board (Kaizen Event) to improve production planning (planning misses reduced by 10%).

Accountable for 55 injection molding machines for 95% or greater attainment.

Production Superintendent February 2009 – January 2010

Metals Department – Fabrication of Cannula (Wielding), Hubs and Inserts.

Responsibilities and Accomplishments:

Utilized Lean Leader and Blue Belt Six Sigma certifications in assisting or leading projects that drive operational excellence in the Metals department.

Drove all Failure Investigations for Non-conforming products utilizing Fishbone diagrams, Actions and Conditions reviews, and Solution Development and Verifications. This was completed with Corrective Action Implementation and a review of Horizontal Deployment.

Collaborated with Green Belt team and implemented SPC in the Metals Department for a 20% reduction in waste for a down steam department.

Implemented OEE in the Metals Department improved by 5% year over year.

Established program for updating and approving all procedures and standard work forms to ensure quality and adhere to regulatory requirements by the FDA.

Exceeded cGMP requirements in the Metals Department.

Enacted a cell redesign (Kaizen Event) project in the TubeMill resulting in decreased transportation, travel, and labor. Savings of $110,000.

Implemented a supermarket inventory system (Kaizen Event) in the Cartridge Printing area of Needle Assembly resulting in $50,000 of inventory savings.

Drove continuous improvement activities such as cell board walks and 5S.

Stimulated activities for safety and production in all departments.

Managed planning and achieved production attainment.

Supervised all maintenance and ensured it was performed correctly and in a timely manner.

Implemented cross-training activities of associates resulting in increased skill level and increased staffing flexibility.

Encouraged pride and workmanship in all associates through communication resulting in improved material variance and OEE.

Improved overall financial success of the Metals Department to include variable overhead, labor efficiency, and material variance.

Sr. Production Supervisor December 2005 – January 2009

Responsibilities and Accomplishments:

Responsible for the safety, supervision, and production activities of 60+ employees.

Guided 2 Kaizen events in inventory reduction and SMED achieving Lean Leader certification resulting in savings of $75,000 exceeding goal by $25,000.

Coordinated and lead 2 Kaizens annually to reduce cost and increase quality output resulting in $235,000 overall savings.

Continuous interaction with upper management, quality, and engineering for advice on process/product improvements.

Maintained and encouraged cross-training activities amongst associates to maximize skills and reduce labor cost.

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