Plant Operations Manufacturing Process

Vince E. Tolson

**** ******** **. ********, **** 43830

614-***-**** *********@*****.***

PLANT OPERATIONS & PRODUCTION ENGINEERING / MANUFACTURING PROCESS ENGINEERING

Twenty-Seven-year track record of success in broad-based aspects of Plant Operations, project leadership, product engineering, innovative design, and production management in the pharmaceutical manufacturing & Bio Medical environments. Expansive knowledge of manufacturing processes, process design, and process improvements. Expert in bringing multiple projects to completion simultaneously. Goal-driven approach to managing time, strategic planning, problem solving and organization. Natural leader, demonstrating strong communication with diverse groups and at different corporate levels. Areas of expertise:

Project Lifecycle Management Solids / Liquids Equipment Support

Supplier / Vendor Relations New Process Support

Budgeting / Cost Control Design / Ordering of Equipment

Scaling Up / Down of Products Preparing Support Documents

CAREER HIGHLIGHTS

Amplifybio

Associate Director Facilities Maintenance & Utilities 2023 - Present

- Building a team from ground up across three different sites. Design and development of a new MFG. process. Supporting plant operations to further develop MFG. processes, optimization as well as overall equipment/Facility utilization. Support of the manufacturing process with preventive maintenance, daily trouble shooting and budgeting of Facilities cost. Identify opportunities for coast savings with energy.

Quidel Athens, Ohio

Sr. Manager Engineering/Facilities & Maintenance 2014 - 2023

- Building an Engineering team from ground up. Design and development of a new MFG. process. Supporting plant operations to further develop MFG. processes, optimization as well as overall equipment utilization. Support of the manufacturing process with preventive maintenance, daily trouble shooting and budgeting of Facilities cost. Identify opportunities for coast savings with energy.

Mylan Pharmaceuticals, Inc. Morgantown, WV 2010-2014

Engineer, Quality Compliance Facilities Equipment

- Responsible for design and purchase of all New Technology. Responsible for providing Engineering support for all equipment in solids manufacturing. Performing Quality audits around the globe for Equipment/Facilities readiness of FDA tours and other agencies. Project management for CIP/Fluidbeds, Cleaning Solution changeover and 5’s throughout manufacturing.

Production Manager

- Responsible for Approximately 300 direct reports working in Granulation/Fluidbed, Coating, Milling,Encapsulation, Blending and Compaction.

- Lead process improvement initiatives as identified in the Balanced Scorecard process, while minimizing risk of business interruptions.

- Identify opportunities and implement strategic solutions aligned with Site Metrics, Business Objectives and Site Strategy.

- Collaborate with existing functional and/or cross-functional improvement teams to drive tactical solutions to assigned areas of focus.

- Define/track performance for key KPI s. Clearly quantify/communicate improvement targets/benefits, both theoretical and actual.

- Ensure projects are fully visible to the site by communicating project milestones/successes on a regular basis.

- Ensure proper training is initiated to support the process implementation changes as they occur to maintain consistency in process execution.

- Perform gap analysis and design project scopes & goals to align with the overall company goals

Eurand Pharmaceuticals, Inc. Vandalia, Ohio 09-2010

Production/Process Engineer

Responsible for Providing Scale-up Experience for Bin Blending. Gravity Feeding Processes. All New Technology.

BOEHRINGER-INGELHEIM ROXANE, INC. Columbus, OH 1994-2009

Production/Process Engineer

Responsible for providing Engineering support for all equipment in solids and non-solids manufacturing. Design and order all equipment for production to make a process more robust or to achieve a higher capacity. Prepare URS, FS, and FAT documents for all new equipment. Perform in-process testing for trouble shooting of new Technology such as the Fette 2090/2090i Tablet Presses and MG2-G140 Encapsulators. Supporting on average 12 Mechanics in everyday troubleshooting for these areas.

Process Engineer / Production Technology 2000 - 2006

Provided technical support and troubleshooting for all of solids manufacturing. Executed IQ, OQ, and PQ protocols for the following equipment: Zanchetta One-Pot Processor, Sigma/Ribbon Fixed and Portable Blenders, Tote Bin Tumblers with 50 – 2000L storage bins, Tote CIP Bin Washer, Alexanderwerk, Quadro Comil, Fitzpatrick Mill, Stokes Oscillator, Gratex Tablet Dedusters, Watson Marlow and Masterflex Peristaltic Pumps. Scale up/down of research and development batches to full-size production batches using experimental design. Reviewed and improved potential processes for new incoming products. Provided support to product development during the early stages of processing to enhance productivity. Provided cost analysis for processes. Determined practical lot sizes for manufacturing based on market forecast.

Technical Affairs Specialist 1998 – 2000

Scaled up research and development batches to full-size production batches using experimental design. Process improvements for solids processing including recommending changes under SUPAC. Investigated out of specification results for batches and concluded as to why it occurred and pass/fail within regulatory justifications. Performed

quarterly trend analysis on all out of specification occurrences and made recommendations for corrective measures to eliminate reoccurrence.

Production Lead / Solids Manufacturing 1994 - 1998

Executed and documented production batches. Trained according to cGMP guidelines. Lead technician overseeing other operators and assisted in training and scheduling batches for production.

EDUCATION & TRAINING

Muskingum College – 1 yr - Business Administration

Ohio Valley Christian College – 3 yr - Business Administration

WCCC - Certified Auto Mechanic Technician

Building Budgeting Skills – Rockhurst University

Regulatory Compliance in the Industry

Certified Trainer on Glatt Fluid Bed, Zanchetta One Pot Rotary Granulators

DEA Observer

Quality Approver

Six Sigma – On Going

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