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Manager Manufacturing

Location:
Baltimore, Maryland, United States
Posted:
January 05, 2018

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Timothy J. Riggie *** E. Melrose Ave., Baltimore, MD 21212

Senior Pharmaceutical Executive 716-***-****

Manufacturing Site Management Operations ac3xbz@r.postjobfree.com

Executive Profile

Quality focused manufacturing professional with extensive operations management experience. Successful record of increasing productivity while reducing costs, improving operational procedures and establishing employee involvement programs. Knowledgeable and experienced in maintaining compliance with FDA and DEA regulations. Strong analytical, communication and organizational skills developed through career advancement as Plant Controller, Materials Manager and Director of Manufacturing. Trained in the LEAN process – Kaizen, 5S, Value Stream and Green Belt. Empower direct reports to meet goals and objectives and hold them accountable for them.

Professional Experience

JUBILANT HOLLISTERSTIER 2014 - 2017

Associate Vice President, Sterile Manufacturing Spokane, WA & Montreal, QC

Managed and lead the manufacturing teams responsible for sterile injectable, solid and semi forms across three business units at two facilities in North America. Responsible for all operational functions, including Manufacturing, Supply Chain, Engineering/Maintenance, Validation, Tech Service and BE. Supported business development efforts and cultivating organic growth opportunities across approximately 30 client relationships.

Directed the Operation’s compliance remediation efforts in lifting the FDA’s warning letter in 18 months

Developed strategic planning which resulted in a 13% increase in revenue and a 100% increase in EBITDA

Increased filling yields by 3% to 95%

Manage an operation budget of $52 million and a yearly capital budget of between $10-20 million

Responsible for the BE activities which generated ~ $4 million annually

Developed strategic plans to double revenue and increase EBITDA to 20% over the next 4 years

Managing the implementation of processes to improve quality and efficiency

PROTOCOL LINK, INC. 2013 - 2014

Senior Consultant Vernon Hill, IL

Provided investigational management and cGMP compliance consulting services to client’s Operations group.

Due Diligence and Site Assessment of a Sterile Injectable facility in China

Provided compliance remediation services in support of a solid dosage facility

Investigation Management in support of a solid dosage Manufacturing Operations

Managed root cause analysis in support of investigations

Managed the execution of corrective action plans

Validated tube and foil filling equipment and packaging lines at a ointment facility

VALIDANT 2012

Senior Consultant San Francisco, CA

Provided leadership and management oversight for the Fill/Finish operation.

Served as Acting Director of Manufacturing – Fill/Finish Department

Management and execution of operational tasks

Implemented processes to improve quality and compliance

Professional Experience (Continued) Page 2

Managed client filling projects

Supported new business development activities

CANGENE bioPharma, Inc. 2003 - 2012

Director of Manufacturing Baltimore, MD

Directed all manufacturing at the Baltimore facility including Filling, Sterilization, Formulation, Lyophilization, Inspection, Packaging, Distribution, Warehousing, Purchasing and Inventory/Planning. Responsible for 3 managers, 6 supervisors and 43 hourly employees. Managed $10 million expense budget for the operating group.

Successfully increased production levels over 100% with only increasing the direct labor workforce by 50%

Managed the installation and validation of a new filling line on schedule and on budget

Increased filling yields by 7% to 95%

As a Management Team member, contributed to successful FDA inspections for both GMP and pre-approvals

Managed operation budget of $2.5 million and a capital budget of $2 million

Developed strategic planning and managed resources to meet the revenue projections of $30 million

Implemented an Aseptic Technique/Behavior Training Program

Implemented many new procedures to improve compliance and efficiency

Directed the implementation of the LEAN process for the operation group

ALPHARMA, INC. 2002 - 2003

Manufacturing Manager / QSCAP Manager Baltimore, MD

Directed all manufacturing at the Baltimore facility including Formulation, Bulk Liquid and DI Water System. Responsible for 75 direct labor employees and 7 supervisors. Managed $5 million expense budget for the operating group.

Implemented many new procedures to improve compliance and efficiency

Successfully increased the staffing for the department to meet the cGMP compliance requirements at the facility

Implemented cleaning procedures for bulk liquid storage tanks

A member of the ongoing QSCAP (Quality System Corrective Action Plan) team, which is responsible for assessing, recommending and implementing improvements to the manufacturing quality systems

PROTOCOL LINK, INC. 2002

Independent Consultant Vernon Hill, IL

Provide management and cGMP compliance consulting services to client’s Operations group.

Served as Acting Manufacturing Manager

Assistance with review and resolution of variance reports

Management and execution of operational tasks

Coordination and implementation of related cGMP documentation

AMERICAN PHARMACEUTICAL PARTNERS, INC. (Fresenius Kabi) 1980 - 2002

Director of Production (1997 – 2002) Buffalo, NY

Directed all manufacturing at the Grand Island facility including Filling, Sterilization, Formulation, Inspection, and Packaging. Responsible for 200 direct labor employees and 12 supervisors. Managed $10 million expense budget for the operating group.

Professional Experience (Continued) Page 3

Successfully increased production levels from 65 million units to 150 million units and increased the direct labor workforce from 100 to 200 over a two-year period

Increased productivity by 26% and reduced labor costs per unit by 22% through new equipment and procedural changes

Contributed to the installation and validation of three new packaging lines, one new vial washer and one new filling line

Increased filling yields to 98.5% over the last three years, while decreasing defects per million by 16%

Participated in a departmental Re-rationalization Program in an effort to improve and unify procedures, systems and processes between two plants

As Management Team member, contributed to successful FDA inspections for both GMP and pre-approvals

Production Manager (1995 – 1997)

Managed all manufacturing activates at the Sterile Power facility including Filling, Sterilization, Inspection, and Packaging. Responsible for 20 direct labor employees and 2 supervisors. Managed $2 million expense budget for the operating group.

Successfully set up a work force that handled filling one day and inspected and packaged the next.

Increased production levels from 1 million units to 5 million units in three years.

Increased filling yields from 91.5% to 94.5% over the three years.

As Management Team member, contributed to successful FDA inspections for both GMP and pre-approvals.

Materials Manager (1993-1995)

Managed all scheduling, inventory control, purchasing, warehousing, label room and accounting at the Grand Island facility.

Implemented quarterly Quality Control Program with key suppliers to resolve issues with raw materials

Developed an excessive/obsolete Raw Material Tracing System, which reduced inventory levels by 20%

Led the implementation of the site’s computerized shop floor system, which provided real time data and inventory tracking system

Contributed to the successful completion of a sixteen-week FDA plant inspection that achieved removal of the corporation from the FDA’s AIP list

Achieved and maintained 100% customer service levels (no stock outs) of 86 product codes for three consecutive years, while simultaneously reducing finished goods inventory

Plant Controller (1980 – 1993)

Education

University of Baltimore, Merrick School of Business

B.S., Business Administration, Management Concentration

Bryant & Stratton Business Institute

AAS Accounting

Professional Affiliations and Societies

The International Society for Pharmaceutical Engineering (ISPE)

The Parenteral Drug Association (PDA)

Sigma Iota Epsilon, The National Honorary and Professional Management Fraternity

Merrick School of Business Honor Society



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