Gene A. Jones

West Chester, OH 317-***-**** acur0t@r.postjobfree.com

Pharmaceutical/Biotechnology Manufacturing Supervisor

Change Leadership Process & Productivity Improvements Lean Manufacturing

Goal-Achieving and People-Centric Production Strategist, leveraging Lean management strengths to streamline processes, fulfill customer specifications, ensure cGMP compliance, and exceed production quality and scheduling goals for industry-leading Fortune 500 pharmaceutical, biotech, and food-grade enterprises.

Proven record of significantly reducing clean-room turnaround times for manufacturers such as Eli Lilly and Cardinal Health.

Keen and agile process engineering and optimization abilities used to analyze, develop, and boost production line efficiencies.

Empowering team leader, skilled in assessing organizational strengths and developmental needs and leading training initiatives to elevate employee engagement and propel productivity gains.

Affable and clear communicator; effective in connecting at all levels, across technical capabilities, as well as cultural backgrounds.

Highly responsive and proactive in adjusting to changes in production requirements, expectations, and accountabilities.

Stellar history of professional commitment, missing only two days of work throughout career.

Professional Experience

AstraZeneca Pharmaceuticals Bristol-Myers Squibb Amylin Pharmaceuticals, Cincinnati, OH

Production Supervisor, Bulk (Compounding for exenatide extended-release (Bydureon)), 2010 – Present

Following a complex acquisition, FTSE 100-listed AstraZeneca the world's seventh-largest pharmaceutical company with an estimated $US24B in annual revenue now heads the manufacture of Bydureon.

Direct day-to-day API compounding operations to support production of the first and only once-a-week drug to help type 2 diabetics maintain stable glucose levels. Schedule, lead, train, mentor, and assess a team of eight in adhering to safety guidelines and accomplishing daily production goals and timelines in fast-moving, dynamic conditions. Monitor and regularly communicate process status to senior manager and internal customers.

Played a valuable role in amplifying production volume 14 fold and expanding manufacturing capabilities from one to two lines and spray dryers from one to five over the course of six-year tenure.

Precisely measured, dispensed, and processed APIs in a sterile-filling, FDA-regulated facility.

Oversaw two production lines, including implementation of sophisticated Micro-Sphere technology; promptly troubleshot and resolved any employee and manufacturing process issues.

Consistently met all production timelines even when running operations with half of a full staff.

Participated in Kaizen events; conducted safety meetings and trainings; ensured all personnel training requirements were current and compliant with GMP criteria.

Assisted in documenting and revising SOPs; submitted deviation reports within 24 hours of occurrence.

Planned and coordinated preventive, routine, and non-scheduled maintenance for all equipment.

Lonza Biologics, Portsmouth, NH

Production & Support Supervisor, Upstream & Downstream, 2006 - 2010

One of the world's leading suppliers to the life science, pharma, biotech, and specialty ingredient markets with ~US$3.8B in annual revenue.

Succeeded in overseeing multi-departmental floor operations and consistently meeting purity and quality requirements for customer orders in demanding and frequently changing contract manufacturing environment. Forecasted and controlled indirect materials and overtime budgets. Administered daily production schedules and material/batch records; adjusted workloads; prioritized and delegated shift assignments.

Facilitated upstream production by providing media and material while concurrently supervising and supporting staff and operations in completing downstream product purification processes.

Corrected identified gaps in formal technical and GMP training by instructing staff and leading 5S/6S exercises on the manufacturing floor.

Optimized production by facilitating cross-functional flow of work orders, dispensing, PMs and quality control (QC) departments.

Cardinal Health, Albuquerque, NM (Facility divested in 2006)

Supervisor, Sterile Filling, 2005 – 2006

Fortune 500 ranked, leading healthcare industry products and services provider with ~$19B in annual revenue.

Accelerated production time lines by leveraging knowledge of aseptic systems and Six Sigma principles to train, develop, and motivate an inexperienced team of 25 non-union employees in departmental procedures and best cleanroom practices. Hired, scheduled, supervised, and evaluated workforce. Managed raw materials inventory; controlled and coordinated flow of raw materials and packaging. Encouraged adherence to quality standards.

Reduced cleanroom turnaround time by two hours along with overall production time by streamlining the manufacturing process for both oral and injectable drug production.

Evaluated engineering changes; outlined appropriate responses and procedures.

Ensured all equipment/process lines adhered to standard operating procedures (SOPs) and current good manufacturing practice (cGMP) regulations.

Eli Lilly & Company, Indianapolis, IN

Team Lead, Aseptic Area Tech I, 2001 – 2005

Publicly traded Fortune 500 global pharmaceutical company then generating ~$18B+ in annual revenue.

Identified and acted on opportunities to improve productivity after rapidly learning production planning and scheduling procedures, gaining skill in cleanroom aseptic equipment setup, and acquiring an understanding of raw materials and packaging logistics and flow. Monitored and evaluated all facets of manufacturing process.

Increased production by preventing downtime, decreasing set-up time, and reducing cleanroom turnaround time by three hours with better training programs and more efficient processes.

Established new hire training system for cleanroom protocols; raised employee involvement and morale by listening to workforce feedback and incorporating valuable suggestions.

Upheld and ensured compliance with FDA regulations while managing critical dose-control process.

Set up other shifts for success; aided in redesign of manufacturing process as SMED committee member; contributed to eliminating production safety issues in the “Near Miss Program” as Job Safety Analyst (JSA).

Early Career Experience

Process / Chemical Operator – Natural Starch & Chemical, Indianapolis, IN

Process Operator Water Treatment Operator – A.E. Staley Manufacturing, Co., Decatur, IL

Education & Credentials

PURDUE UNIVERSITY, Indianapolis, IN

Bachelor of Science (BS), Organizational Leadership and Supervision, Anticipated 2019

Associate of Science (AS), Organizational Leadership and Supervision

Earned certifications in Quality Assurance, Leadership, Six Sigma Green Belt, ISO 9002, and Human Resources as part of academic studies.

Obtained the following additional certifications through professional development: Pharmaceutical Equipment, Aseptic, Hazardous Chemicals, Industrial Safety, Respirators, Forklift Trucks

Professional Affiliation: American Society of Quality (ASQ), Member since 2004

Computer Proficiencies

Windows, Microsoft Office Suite (Word, Excel, PowerPoint), SAP, Trackwise, Maximo, Lotus Notes, Minitab 14, LIMS, Delta V

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