Manager Plant

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

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

Site Management Operations Manufacturing **************@*****.***

Executive Profile

Quality focused manufacturing professional with extensive site management and operations 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, EU 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 by holding them accountable.

Professional Experience

IMPRIMIS PHARMACEUTICAL 1/2018- 8/2019

General Manager NJOF Ledgewood, NJ

Site head for the New Jersey 503B outsourcing facility, the site is focused on sterile ophthalmology pharmaceutical products including injectable vials and eye drops. Responsible for the P&L and all operational functions, including Manufacturing, Supply Chain, Engineering/Maintenance, Validation, and Tech Service. Support business development efforts and process improvements.

Manage an operation budget of $30 million and a yearly capital budget of between $2 to $3 million

Developed strategic plans to increase revenue by 28.5% and increase EBITDA by $3 million

Managing the implementation of processes to improve efficiency

Increased filling yields by 5% to 93%

Developed 7 new products for commercialization

Developed safety program

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

Professional Experience (Continued) Page 2

PROTOCOL LINK, INC. 2012- 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 an ointment facility

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

Served as Acting Director of Manufacturing – Fill/Finish Department

Management the execution of operational tasks

Implemented processes to improve quality and compliance

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

Professional Experience (Continued) Page 3

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) Grand Island, 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.

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 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)

Materials Manager (1993-1995)

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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