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Supervisor Manufacturing

Location:
United States
Posted:
March 27, 2015

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Resume:

PHILIP J. GARDENER

**** ********** ***** ****, ** 27502

919-***-**** acow0d@r.postjobfree.com www.linkedin.com/philgardener

QUALIFICATIONS SUMMARY

Manufacturing Supervisor with strong background in vaccine production within global

pharmaceutical manufacturing companies. Skilled in all aspects of fermentation and purification

processes. Highly effective in communicating across departmental lines to resolve production

issues. Demonstrated ability for effectively managing challenging projects. Expertise includes:

Facility & Equipment Compliance SOP Creation & Management

Production Schedules Technician Training & Coaching

Training Protocol Development Batch Record Documentation

Production Changeover & Shutdown Manufacturing Deviation Control

PROFESSIONAL EXPERIENCE

HOSPIRA – CLAYTON, NC 2011-2015

Manufacturing Supervisor

Supervised technicians in formulation, filling and drug weigh operations in a multi-shift operation.

Ensured operations adhere to GMP standards in meeting production schedule.

Collaborated with site Lean Department to create and implement standards to increase

effectiveness of operations.

Developed and revised SOP’s to improve manufacturing performance and compliance. SOP’s

included the development of a production hose management procedure, revisions of a major

batch production record, and designing a technician training program.

Assisted with the validation and implementation of process to increase production capacity, while

reducing cost of manufacturing.

PFIZER (FORMERLY WYETH) – Sanford, NC 2002 to 2010

Manufacturing Supervisor, Purification and Fermentation (2002 – 2010)

Supervised technicians in multi-shift operation to meet production schedule while maintaining

GMP compliance. Managed day to day floor operations involving up to 15 technicians and

communicated with support groups to resolve ongoing production issues.

Led campaign to resume production of purification area. Trained technicians, revised SOPs, and

qualified equipment in order to meet production goals.

Volunteered for annual shutdown of production area in 2007 and 2008. Provided oversight in

collaboration with QA, QC, and Engineering to facilitate area release for GMP production on

schedule, allowing achievement of production goals for both years.

Partnered with maintenance and engineering to ensure GMP compliance of facility equipment,

sustaining equipment availability against production schedule which permitted both engineering

and manufacturing to complete site requirements on schedule.

Developed and implemented real-time document review program that significantly reduced batch

record errors, leading to faster release of completed batches.

Directed team of supervisors and technicians to expedite standards for performance evaluation.

Organized meetings to provide feedback and build consensus, then created consistent and fair

rating template.

Managed implementation of media fill qualifications for department personnel. Revised media fill

procedure and trained personnel. Allowed department to meet FDA guidelines for aseptic filling of

bulk product.

PHILIP J. GARDENER acow0d@r.postjobfree.com

Achieved production goals regarding quantity and quality of product produced as the only

supervisor in multiple shift operation. Worked with leads on both shifts to increase communication

to manage production issues appropriately.

JOHNSON CONTROLS / GLAXOSMITHKLINE – Zebulon, NC 1994 – 2002

Maintenance Planner / Database Administrator (1998 – 2002)

Planned and scheduled work for 15 mechanics and calibration technicians maintaining facility

operations.

Developed and implemented automated calibration system. Determined calibration parameters for

50+ different types of instruments. Increased number of calibrations completed on daily basis by

reducing calibration paperwork.

Planned and scheduled floor repair of 5000 sq. ft. manufacturing area around production

schedule. Organized meetings with floor repair contractor and production department to determine

area availability. Completed floor repair enabled site to maintain manufacturing area in a GMP

compliant state while meeting production goals.

Lead Technician, Calibrations (1994 – 1998)

Supervised calibration technicians for timely completion of 4000+ calibrations per year. Processed

preventive / corrective work orders according to cGMP and FDA regulations.

Led effort to execute validation protocols on all facility air handling equipment. Scheduled

downtime with production, coordinated testing with validation, and executed protocol.

Completed required testing of all equipment on schedule.

EDUCATION & TRAINING

Bachelor of Science, Industrial Technology, Southern Illinois University

Professional Development

Wyeth 21st Century Supervisor Program

Wyeth Supervisory / Management Development Curriculum

PDA (Parenteral Drug Association) Aseptic Operations

Dale Carnegie Skills For Success

Technical Proficiencies

Microsoft Word, Excel, Outlook

SAP Solutions Software



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