Chad G. Hutson

***** *** ****** *****

Whitehouse, OH 43571

419-***-****

acruga@r.postjobfree.com

Education: Defiance College University of Toledo Wright State University

Bachelor of Science Pre-Med Program MBA

Business Mgmt Chemistry Operations Mgmt

Graduated 1995 Attended 1988-1991 12.0 Core Hours Completed

Ohio State University (MoreSteam), Lean Six Sigma Black Belt - Certified 2009

ISPE – Root Cause Analysis 2007

ISPE – Corrective Action / Preventative Action 2006

GMP Institute – Level 1, 2, 3 Compliance Training 1998 - 2001

Experience: Medline Industries – Pharma/OTC/Medical Device MFG, Cincinnati, OH

Vice President of Manufacturing

Oversee Engineering, Manufacturing, Supply Chain, Maintenance, Sales, Logistics, Packaging and HR. Responsible for Plant P&L, Capital Projects, Facility Maintenance and FDA follow-up responses. Reduced product back-order from $800K to $125K in (4) months. Improved On-Time-Delivery from 82% to 92% in (3) months. Experienced most profitable month from Operating Income standpoint over past 8 years. Implemented monthly cGMP training, employee morale improvement initiative, Lean MFG principles, facility KPIs. Hold weekly discussions on NCR/Deviations, along with Root Cause analysis and CAPA initiatives with site MGRs. Coordinating process and cleaning validation work for upcoming NDA and PAI. Champion of pending facility closure, including product transfer, equipment relocation, finished goods re-costing (possible SKU reduction), inventory safety stock build, balance facility headcount.

April 2015 - Present – Facility to close 2016 Q1

Fresenius Medical Care – Medical Device MFG, Oregon, OH

Plant Manager

Oversaw Engineering, Manufacturing, Dry and Liquid Packaging, Logistics and Supply-Chain. Ensured facility and personnel were cGMP, ISO13485 and FDA compliant. Established training matrix for individual employees in conjunction with performance based accountability assessment. Reduced annual customer complaints by 32 % through utilization of accurate Root Cause analysis and increased CAPA initiations. Established annual facility budget and maintained monthly P&L. Championed capital projects pertaining to new product line and facility/equipment upgrades. Introduced facility to KPIs, Lean MFG principles, OEE monitoring and 5S program. Reduced facility OT from 40% to 15%. Implemented Employee Recognition program and monthly one-on-one focus meetings in order to improve employee morale.

June 2014 – April 2015 – Accepted position of increased responsibilities

Universal Cooperatives, Agricultural Chemical MFG, Napoleon, OH

Plant Manager

Oversaw all plant operations pertaining to Procurement, Supply-Chain,

Formulation, Blending, Packaging, Maintenance, Logistics and QC laboratory functions. Ensured facility and personnel are EPA/OSHA compliant. Provided direction for product flow to meet customer product demands. Eliminated requirement of temporary contract employees through standardization of continuous process concepts and production schedule. Worked with vendors regarding material costs and incoming quality. Handled all customer complaints/product deviations through a CAPA procedure linked to ISO9001. Constructed monthly/annual operations budget, responsible for plant P&L. Ensured all plant personnel were properly trained on OSHA safety policies, job functions and EPA requirements (hazmat handling, spills, emissions, PPE requirements). Maintained all EPA required operating permits.

June 2013 - June 2014 – Company divested all MFG Operations (Chapter 11)

Patheon Pharmaceuticals, Pharmaceutical Manufacturer, Cincinnati, OH

Manufacturing Manager

Managed 9 direct reports with ~180 indirect reports in Granulation, Blending, Compression/Encapsulation, Coating, Bulk Packaging. Responsible for schedule adherence/attainment, Client interactions, SOP revisions. Participated in various global regulatory agency audits/follow-up responses/PAI. Involved in CAPA/Root Cause analysis for product/process deviations and customer complaints. Implemented quality systems within manufacturing to achieve Right First Time quality objectives, shared best practice on global scale with other MFG sites. Developed and executed cGMP compliance awareness training. Involved in new product line start-up, change controls, capital expenditures and process development for new incoming products and facility build-out design. Responsible for meeting facility/corporate KPIs, balancing headcount, maintaining department budget. Site Champion for Mindset/Behavior/Culture improvements pertaining to employee morale and work-life balance. Established/Lead cross-functional teams providing direction to support groups (QA, Engineering, Tech Services, Supply Chain). Constructed departmental Visual Management boards depicting department performance. Established annual MFG budgets. Implemented Lunch-n-Learn training program.

March 2010 - June 2013 – Accepted position of increased responsibilities

TEVA (Barr Laboratories), Pharmaceutical Manufacturer, Cincinnati, OH

Manufacturing Supervisor

Supervised thirty direct reports in Compression, Encapsulation, Granulation, Blister Packaging and Dry Blending departments. Approved and finalized weekly and monthly production schedule. Championed continuous process improvement efforts. Worked on cross-functional teams to improve product quality and OTD. Coordinated site transfers and validation batches. Involved with CAPA procedures for customer complaints and process deviations. Conducted quarterly state-of-manufacturing meetings. Met with vendors pertaining to raw material concerns, capital purchases and equipment upgrades. Wrote, reviewed, approved new/ revised SOPs. Responsible for process scrap reduction/yield improvements, increased average batch yield from 95.1% to 97.5% in (3) months with proven sustainability. Executed (2) Six Sigma projects with a combined annual savings of $1.8MM. Ensured all process functions properly executed in SAP. Ensured FDA and cGMP compliance. Assisted in determination of annual MFG budget.

March 2006 - November 2009 – Accepted position of increased responsibilities

Eurand, Pharmaceutical Manufacturer, Vandalia, OH

Production Supervisor/Interim Manufacturing Manager

Supervised three direct and ~forty indirect reports. Coordinated and approved

weekly production schedule pertaining to Glatt fluid-bed dryers, solvent

coascervation system, encapsulators, and fette/hata tablet presses.

Forecasted and maintained annual operations budget. Conducted cGMP audits

and designated parties involved with corrective action. Approved new or

revised SOP’s and protocols. Worked with R&D involving scale-up

projects. Met with vendors and customers regarding orders, quality and

pricing. Scheduled machine time for R&D projects and maintenance PMs.

Reduced batch record errors from 43.2/month to 15.3/month in the first

(2) months of employment. Reduced 2004 scrap total by 63% over 2003.

Worked closely with QC and QA regarding product and procedural issues.

March 2003 - October 2004 – Became stay-at-home parent

Ross Products/Abbott Laboratories, Nutritional Beverages, Sturgis, MI

Production Supervisor, Liquid Processing/Filling and Dry-Blending Dept.

Supervised three crew leaders with thirty direct reports. Created weekly

Processing schedule based on Division’s needs. Monitored incoming

chemicals and billing for entire facility. Maintained and forecasted

$1.2MM chemical budget. Provided upper management with weekly

production report covering three operating shifts. Conducted cGMP audits

with internal and external auditors. Reviewed batch records for

correct documentation prior to QA review. Held monthly meetings with upper

management, peers, and operators. Mentored and coached operators

during monthly one-on-one discussions. Set facility record for pounds of

product produced in a shift/week/month. Calculated Finished Goods optimization additions per established product specifications.

July 2001 - January 2003 – Spouse Transferred to Dayton, OH

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