Project Manager Manufacturing

JAMES P. BEGANI

***** ** **** ******* • Kansas City, Mo 64152

Phone 816-***-**** (Cell) • E-Mail *****@*****.***

SUMMARY OF QUALIFICATIONS

Over thirty years of industrial cGMP experience in the manufacturing and validation of biological and chemical based APIs, the formulation and filling of aseptic and non-aseptic liquid products, and biopharmaceutical manufacturing methods.

Managed $1M+ budgets for projects and company.

Led and managed multi-disciplinary teams for new and renovation construction and validation projects.

Directed and oversaw the implementation of an in-depth training and professional development program for validation personnel.

Involved in various aspects of process, system and equipment validation, including commissioning and qualification activities for over twenty years.

Implemented project definition and control methods on multiple cGMP construction/installation/upgrade projects utilizing project management methods and the Cx process, from conceptualization, to the initial and detailed design phases, through construction, commissioning & start-up, and qualification/validation and turn-over.

Implemented the 2005 ASHRAE Commissioning Process for several projects to manage overall project quality, delivery and expediting the qualification/validation phase.

Expert in moist heat steam sterilization (SIP, autoclaves) cycle development and validation per PDA, EN285 and AAMI standards.

Demonstrated and proven project management abilities and skills working with multi-disciplinary teams for commissioning &start-up and qualification of facilities and equipment used in the manufacturing of pharmaceutical and biotech products.

Demonstrated ability to understand regulatory and compliance issues and designing and implementing facility operation plans that comply with FDA, UK and EU regulations

Proven experience in the training of project teams and knowledge transfer.

PROFESSIONAL EXPERIENCE

QVM Services Kansas City, MO

November 1993 to Present

President / CQV Project Manager and Lead

Founded and oversaw operations of a commissioning / validation services and consulting firm.

Managed numerous CQV projects from inception to validation and turn-over.

Prepared project planning documents, including Validation Master/Project Plans, Commissioning Plans for Design Phase and Construction Phase, Training Plans for owner staff members, and Project Control Plans and Procedures.

Provided strategic planning and direction to the company, including budget and financial planning, business planning, and overseeing sales and marketing efforts.

Directed the development and implementation of a Quality Management System.

Directed the development and implementation of a robust Training Program on qualification/validation methods and skills.

Experienced in Commissioning, IQ, OQ and PQ execution for equipment, utilities and systems, as well as, process validation, sterilization/disinfectant/sanitization validation and cleaning validation.

Project experience in aseptic formulation and filling operations, bio-processing operations, vaccine manufacturing operations and non-sterile dosage forms.

Experience includes support and clean utilities, overall facility operations, fermenters/fermentation and bio-reactors, down stream processing equipment, formulation and filing equipment, HVAC and Clean Room, autoclaves and SIP processes, manual and clean-in place processes, and lyophilization / freeze driers.

Clark, Richardson and Biskup, Kansas City, MO

November 1992 to November 1993

Senior Validation Specialist / CQV Project Manager

Prepared and executed protocols for expansion of the USP Water System and installation of new deionized water recirculation loop and Pure Steam system

Performed weld inspection of high purity piping systems

Oversaw and consulted on the installation and validation of critical utilities and equipment for a fermentation and parenteral pilot plant for the preparation of parenteral biotech products.

Acted as interim validation manager and validation consultant for SBAH manufacturing

PROFESSIONAL EXPERIENCE (Continued)

Triad Technologies (Jacobs Engineering), New Castle DE

July 1990 to October 1992

Manager, Qualification & Validation / QV Project Manager

Responsible for development and maintenance of in-house cGMP compliance program for the Q/V department

Coordinated and delegated project tasks of protocol preparation and execution to department personnel

Provided technical input and support on validation issues and requirements for engineering and validation projects and developed and executed protocols for utilities and equipment for biopharmaceutical and parenteral facilities

Developed, implemented and conducted a high purity piping installation inspection program for a client which included verification of installation (slope, routing, insulation, etc.), materials of construction (heat cert) reviews, and review of weld inspection videotapes.

Managed and provided process engineering and coordination of process equipment and utility sizing and routing (USP Purified Water, WFI and Clean Steam)

Documented and qualified the modification of existing utilities (Plant Steam, Cooling Water, Compressed Air and Nitrogen)

Lead the Specification, selection and inspection of parenteral manufacturing equipment, including stopper washer, rotary bottle washer, radiant depyrogenation tunnel and filler/stopper machine

Designed and specified the equipment for a steam-in-place sterile filler reservoir tank and sterilizing filter for the sterile transfer of formulation from formulation hold to the reservoir and manifold

Coordinated the validation efforts of Triad and client personnel of all utilities and parenteral equipment, construction QC support and protocol execution

Skyland Scientific, Raleigh, NC

June 1989 to July 1990

Technical Sales Manager / Validation Specialist

Developed the Southeast as a market for continuing growth for validation and related services and administrated daily operations of the Raleigh office

Interviewed clients to determine needs for validation and developed and presented proposals

Reviewed and red-lined P&IDs, conducted design review and facility audits, prepared as-built punch-list issues, reviewed and identified CIP/SIP circuit boundaries and pathways, and wrote SOPs.

Qualified dry heat ovens, bio-processing tanks, including CIP/SIP validation, and a lyophilizer

PROFESSIONAL EXPERIENCE (Continued)

Praxis Biologics, Rochester NY / Sanford, NC

March 1986 to June 1989

Manufacturing Supervisor / Research Associate

Trained and supervised operators in the fermentation, separation and purification areas for biologicals for GMP processes.

Scheduled daily and weekly work assignments for operators.

Motivated and maintained a "high quality of work" attitude among operators during second and third shift operations.

Oversaw and performed CIP and SIP of tanks, fermenters and other process equipment associated with vaccine production.

Responsible for the start-up and qualification of MP/UF filtration systems for the North Carolina manufacturing facility

Worked as part of a technology transfer team which developed SOPs and batch records, reviewed and monitored the installation and qualification of systems and equipment, and conducted the initial process validation of the vaccine fermentation, purification and conjugation, which resulted in a successful FDA facility inspection and licensing.

Wrote batch records and standard operating procedures for the synthesis and purification of oligosaccharide

Supervised operators of three months for processing consistency lots as part of the facility/process validation

Designed operated and prepared SOPs for CIP and SIP circuits of piping, process tanks and processing equipment

Responsible for the installation and final punch list for the chemistry manufacturing suite (conjugation process).

Developed chemical processes to provide consistent yields

Developed and optimized a HPLC separation/purification process for the oligosaccharide which increased yield by 50% higher than the research scale.

Bristol-Myers Industrial Division, Syracuse, NY

August 1981 to March 1986

Research Associate

Validated new chemical processing steps and purification steps at the pilot plant scale.

Designed, developed and improved processes which were implemented in pilot plant operations

Produced clinical supplies of beta-lactams under GMPs

EDUCATION

Graduate Studies in Chemistry, 1982 to 1986

SYRACUSE UNIVERSITY and STATE UNIVERSITY OF NEW YORK OF SYRACUSE • Syracuse, NY

Bachelor of Science/Chemistry, May 1981

CLARKSON UNIVERSITY • Potsdam, NY

PRESENTATIONS AND PUBLICATIONS

Co-trainer/educator on “cGMP, Documentation and CQV for Medical Devices and Pharmaceuticals”, Anoka-Ramsey Community College, Coon Rapids, MN. May 2006.

“Effective Validation of HVAC Systems” and “Working Effectively with Existing or Legacy Systems--The Problem of Re-qualification/Revalidation.” Presented at “Validating Utilities: Applying the Best Validation Practices to Air, Water & HVAC” The Validation Institute, a division of the Institute for International Research, July 1998

Co-presenter at "How to Prepare Protocols" International Society of Pharmaceutical Engineers, Philadelphia Seminars, September 1993

"Biotechnical Plant Validation" Presented at Merck and Co., 1991 Engineering and Technology Conference, September 1991

“Synthesis of 14-Alkylated Morphinans,” Thesis, Clarkson (College) University, 1981.

PROFESSIONAL MEMBERSHIPS

Parenteral Drug Association

International Society of Pharmaceutical Engineers

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