Timothy P. Call

**** ****** **** ****: 716-***-****

Amherst, New York 14226 e-mail: ab82ln@r.postjobfree.com

Professional Summary

Accomplished Manufacturing Operations Director with twenty-seven years of

progressive leadership experience in the pharmaceutical and personal

healthcare industry that has significantly improved operational performance

in the areas of Quality, Productivity, Safety, Delivery, Environment and

Cost.

Functional Expertise:

Pharmaceutical Drug Manufacturing, Process Improvement, Training, Project

Management, Team Building, Employee Development

Manufacturing Expertise:

. Organizational Leadership . Team Building .

Regulatory Compliance

. Process Improvement . Employee Motivation and Career Development

. MRP System Implementation . Formulation, Filling and Packaging

Professional Experience

APP Pharmaceuticals, Grand Island New York

12/2011 to 12/2012

A Fresenius-Kabi Company

Production Cell Manager

Manage all production activities relating to the terminal sterilization and

aseptic filling processes for injectable drug manufacturing. Responsible

for the entire process from scheduling through finished product filling and

capping. Direct Operation Excellence projects to improve line performance

efficiencies, reduce downtime and identify continuous improvement

opportunities. Identify projects to increase batch yields and production

campaigns to optimize production capacity.

Compliance Manager

Oversee Operations compliance to all relevant cGMP's. Coordinate

Corrective And Preventive Actions resulting from internal deviation

investigations and external customer complaints. Prepare site for

internal/external audits, address audit observations and determine

corrective actions. Worked with the Quality management team to prepare

communications with the FDA relating to Field Alerts, 483 and Warning

Letter findings. Identify necessary process improvements to maintain a

state of cGMP compliance.

Lornamead Inc. Tonawanda, New York 2009 - 2011

Manufacturing company specializing in personal care products

Manufacturing Director/Plant Manager (2009 - present)

Direct a staff of employees in manufacturing, maintenance and warehousing

operations, focusing on continuous process improvement, FDA preparedness

and cGMP compliance. Developing standard operating procedures to control

all phases of manufacturing and enhance accountability. Prepare facility

for customer and FDA inspections, with emphasis on improved documentation,

material flow and process improvement.

Creating work order controls for washouts, changeovers and preventive

maintenance

Implement team approach to problem solving, process flow charting, and

Kaizan Events

Aligning department operations to meet quality and productivity objectives

and cGMP compliance.

Astellas Pharma Manufacturing Inc. (Fujisawa), Grand Island, New York

1998 - 2009

Manufacturing division of Astellas Pharma Inc, the world's 17th largest

pharmaceutical company.

Director, Manufacturing Operations (1998 - 2009)

Led a team of six professionals in three functional areas including

manufacturing operations, facility engineering and production maintenance.

Directed an operations staff of 45 direct and indirect labor personnel.

Established short and long-term operational goals. Managed programs for

continuous improvement, cost reduction, and environmental awareness.

Professional Experience (continued)

Represented the manufacturing group in FDA inspections. Ensured regulatory

compliance through the development of standard operating procedures and

company policies. Managed an operating budget in excess of $8 million.

Performed Long Range and Short Term production planning, coordinating

product demand with purchasing groups in Europe, Southeast Asia, North and

South America and the Middle East.

Led the implementation of the Lean Manufacturing philosophy of 5S

throughout the company.

Established Washout Reduction/Continuous Batching plan that increased

capacity and reduced water usage by 25%. Eliminated the need for a planned

manufacturing expansion, saving over $25 million in new construction

expenses.

Implemented a company wide cost savings/process improvement program (TIP

Program) that saved $1.5 million and initiated 80 improvement projects from

2005 to plant closure.

Directed the company ISO 14001 Environmental program to focus on reductions

of: electrical usage, generation of hazardous waste for disposal, water

usage and CO2 emissions. Audited eight times since 2002, with zero non-

conformance observations noted. Launched commercial production of a

prescription drug product, with sales exceeding $100 million within 3 years

of launch.

Maintained strict adherence to organizational standard operations

procedures and policies, resulting in 8 FDA inspections with zero 483

observations for non-compliance with cGMPs.

Member of the Corrective Action/Preventative Actions (CAPA) Team to

investigate negative quality trends and implement corrective measures.

Managed a project to develop Cream and Gel formulations as an alternate

vehicle for delivery of a pharmaceutical active ingredient; resulted in

submission to Phase III clinical trials.

Provided stability and direction during the three-year period in which the

plant was for sale or closing, maintaining product quality standards at

greater than 98.5% Right the First Time.

Coordinated the decommissioning of plant systems and equipment, and

archiving of proprietary documentation to support the plant divestiture.

Directed activities relating to the Product Transfer moving the company's

product to Japan. Acted as "Window Person" for communications/information

transfer with the project leaders in Japan.

Westwood-Squibb Inc., Buffalo, New York 1985 - 1998

Subsidiary of Bristol Myers-Squibb, global manufacturer of pharmaceutical

prescription & OTC products.

Manufacturing Maintenance Manager (1998)

Directed maintenance staff of twenty technicians in support of a three

shift manufacturing operation. Worked with production management to

coordinate preventive maintenance schedules and routine repairs. Controlled

the budget for maintenance operations and capital spending.

Implemented use of MP2 system for tracking maintenance work orders and

inventory controls.

Plant Shift Manager (1990 - 1998)

Managed a staff of three salaried supervisors and a workforce of forty full

and part-time production workers. Controlled plant operations on third

shift, including bulk formulation, filling, packaging, central pharmacy

weighing, warehousing, QC laboratories, injection blow molding operations,

and plant security. Mentored supervisory staff and prepared them for future

advancement opportunities.

Received the Total Quality Management Leadership Award for participation in

production line efficiency improvements.

Directed the process improvement team that was honored with the

corporations "President's Award" for outstanding improvement project.

Executive Committee member of the Margin Improvement Cost savings program,

influencing and promoting involvement of manufacturing employees across a

24/5 operation and overseeing implementation of approved improvement

projects.

Implemented SMED process for equipment changeovers and washouts.

Initiated a three-tier production worker grading system to offer

advancement and development opportunities.

Professional Experience (continued)

Packaging Supervisor (1987 - 1990)

Supervised all production related activities including filling and

packaging operations. Scheduled production and coordinated staffing to

achieve maximum efficiency and resource utilization.

Contributed to the successful implementation of the Materials Resource

Planning system.

Housekeeping - Plant Services Supervisor (1985 - 1987)

Coordinated the care and cleaning of the overall plant. Managed a staff of

seven custodial personnel to maintain the facility to meet FDA requirements

for cleanliness.

City of Naples Police Department, Naples Florida

1984

Police Officer

Patrol Officer responsible for routine law enforcement duties.

Graduated first in class from the Southwest Florida Criminal Justice

Academy

Education

State University College of New York at Buffalo, Buffalo, New York

BA - Criminal Justice

Training/Development

Situational Leadership Total Quality Management

High Performance Work Teams Hay System for Job Evaluations

Creative Problem Solving Techniques SMED - Single Minute Exchange

of Dies

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