Project Manager Customer Service

MARK F. JONES

**** ******* ***** **** 919-***-****

Knightdale, NC 27545 *********@*****.***

SUMMARY

Quality-oriented Senior Operations Manager with proven success leading production teams to

meet aggressive operational goals. Primary expertise in pharmaceutical operations focusing on

oral solid dose manufacturing and packaging Additional expertise focusing on bulk vaccine

aseptic manufacturing processing in the areas of fermentation, purification and formulation.

Experienced project manager leading cross-functional capital projects focused on the introduction

of new products and process capabilities. Demonstrated competencies leading innovation and

change, driving for results, focusing on customer service and building talent. Hands-on leader

focusing on quality, safety, continuous improvement, and GMP compliance.

LEADERSHIP EXPERTISE

• •

Continuous Improvement Highly Responsive Supply Chain

• •

Lean/Six Sigma Methods GMP/Validation Compliance

• •

Batches Right the First Time Cycle Time Reduction

PROFESSIONAL EXPERIENCE

EISAI, Inc., Research Triangle Park, NC 2005-Sep 2013

Senior Production Manager (Packaging) (2009-2013)

Lead a two-shift high speed packaging operation producing oral solid dose products supplying

global markets. Responsible for meeting and exceeding base business metrics of safety, batches

right the first time (BRTFT), highly responsive supply chain, leading innovation and change,

employee development and continuous improvement.

• Reduced the number of deviations and complaints and improved overall quality by

implementing the use of line clearance checklists and supervisor final inspection prior to

starting production. Saw an immediate reduction in deviations and complaints after

implementing new procedure month-to-month, yielding an 80% improvement in two years and

approaching best in class Quality year-to-date.

• Successfully led the transition from a high-volume production department to a low-volume

specialty packaging department focused on smaller volumes, quick change overs, quick

turnarounds and high quality to break paradigms of previous out dated business model.

• Successfully collaborated with support areas including Planning and Scheduling, Technical

Operations, Quality Operations and Equipment Engineering, in a dynamic team environment

in order to meet very aggressive commercial and new product launch timelines. Met or

exceeded new product launch timelines and maintained commercial product supply with zero

stock outs.

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MARK F. JONES

Production Manager (Manufacturing) (2005-2009)

Managed an oral solid dose (OSD) manufacturing operation. Drove results for manufacturing

processes and employee development focused on improving product yields, reducing cycle time,

improving quality and continuous improvement while ensuring compliance with all regulatory

requirements.

• Reduced the number of scrapped batches by more than 50% in the first year and by 95% in

the second year by communicating the financial impact of lost batches, implementing a

structured training program to ensure consistent performance, and by raising the level of

expectation of all employees and holding them accountable for performance.

• Reduced human and documentation errors by 90% by eliminating manual batch record entries

by automating the process instruction steps electronically in the SAP system.

• Improved batches right the first time (BRTFT) consistently to more than 90% by eliminating

the number of batches discarded due to processing problems. By communicating the financial

impact, formalizing the training process and holding employees accountable realized a

positive impact on quality.

• Reduced the coating process cycle time from 24 hours to less than 20 hours, eliminating

unnecessary overtime over a two-shift operation working 10 hours per shift. Reduced the

overall coating process time by 19% by performing some process steps in parallel rather than

in sequence eliminating the need for overtime.

• Improved overall employee satisfaction by converting from a merit-based pay system to a pay

for skills and knowledge program. Established a set of skills and knowledge that employees

could learn, demonstrate and be assessed on. Received Ovation Award for a mid-size company

on the successful implementation of the pay and progression program.

Merck & Co. – West Point, PA 2002-2003

Project Manager – Encapsulation

Managed the completion of equipment assessments, purchasing, installation and qualification of

the encapsulation process to support a 3x5 shift operation.

Merck & Co. – West Point, PA 2001-2002

Senior Manufacturing Supervisor – Bulk Vaccine Manufacturing

Served as Team Leader for five first line supervisors and 20 union employees in aseptic vaccine

processing involving fermentation, purification and formulation.

Merck & Co. – Wilson, NC 1998-2001

Project Manger

Managed a cross-functional team responsible for the implementation, execution and annual

assessment of the business unit’s cleaning validation program. Served as project manager for all

automated control systems and launch of new products within the manufacturing division and with

joint venture partnerships.

Prior roles include Production Planner, Production Supervisor, and Quality Control Auditor

with Merck & Co.

EDUCATION

MBA, Business Administration, Concentration in Operations Management

East Carolina University, Greenville, NC

BS, Industrial Technology (Electronics)

North Carolina A & T State University, Greensboro, NC

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