Michael Anderson
Decatur,IL
Summary
Previous employment experience has involved high speed manufacturing & packaging, budgeting, planning, personnel development, and direct supervision. I have an extensive manufacturing background that ranges from operating equipment, repairing equipment, and solving manufacturing issues, to supervision, management and ultimately plant management. I also have an extensive validation background which includes commissioning, FAT, SAT, IQ, OQ, PQ performance as well as managing validation teams both domestically and internationally.
Knowledgeable Maintenance Manager with proven history of leading high-performing teams and executing strategic initiatives that drive organizational growth. Successfully directed cross-functional projects that resulted in significant process improvements and operational efficiencies. Demonstrated leadership and communication skills in fostering collaborative environments and delivering impactful results.
Experienced with managing maintenance operations and optimizing equipment performance. Utilizes preventive maintenance programs and efficient troubleshooting techniques to reduce downtime. Knowledge of team leadership and effective communication to achieve operational goals.
Overview
35
35
years of professional experience
Work History
Director, Manufacturing
Rising Pharmaceuticals, Inc
12.2023 - Current
- Responsible for preparation activities for manufacturing operations in a USP Injectable Drug environment. Responsible for the manufacturing activities associated with re-starting a closed pharmaceutical plant. Rising Pharmaceuticals has not manufactured pharmaceutical products previously, and I have been assisting in a start-up effort in their Decatur, IL facility. Three successful Aseptic Process Simulations have been completed by the manufacturing team and were prepared for the first three commercial stability lots when the operation was ceased in September, 2025. I was one of the selected people to remain through the closeout process, shutting down equipment, organizing parts/paperwork/ and tools.
Consultant
Steriqual/NEXA
11.2021 - 12.2023
- Responsible for managing a team of up to 10 Validation Consultants during the execution of multiple projects at Charles River Laboratories Memphis TN Facility and Resilience located in Alachua, FL. Tasks included writing and executing qualification documents associated with the expanded facility and equipment that is used during Cell Gene Therapeutics manufacturing. The work was performed as a consultant for Steriqual LLC which merged with NEXA, a subsidiary of TransCat during this timeframe. The following systems were commissioned or qualified as required: Facility Fit and Finish IOQs, Process Gas Systems, CO2 Incubators, Cell Counters, Centrifuges, Particle Counters, Biological Safety Cabinets, Refrigerators, Cryogenic Freezers, CryoPod Carriers and Fillers, Liquid Nitrogen Distribution, Single Use Equipment including Tanks and BioReactors
Commissioning & Qualification Lead (Plant Utilities)
Compli LLC
01.2020 - 11.2021
- Responsible for writing and executing commissioning and qualification documents associated with the utilities involved in the HPV expansion for Merck Pharmaceuticals located in Elkton, VA and Durham, NC. Performing this work through Compli, LLC which is a subsidiary of GBA in Lenexa, KS. The following systems were commissioned or qualified as required: Clean Steam, Hot Endotoxin Reduced Water System, Ambient Endotoxin Reduced Water System, Process Air, Cooling Water, Chilled Water, Instrument Air, Plant Steam, Electrical, CIP Distribution, Liquid Nitrogen Distribution, Compressed Nitrogen Distribution, Cooling Towers, Water Chillers, Boilers
Plant Manager
BioTechnique/Lyophilization Services of New England
08.2017 - 11.2019
- Responsible for plant activities and overall performance in a pharmaceutical contract manufacturing environment. Oversaw plant renovation during transition period from BioTechnique to LSNE and brought systems back into operation. Met with clients to learn of their products and the challenges that were associated with each product. Assisted technical team with creative solutions for process development for all types of injectable pharmaceutical products. Hired staff to manage various areas of responsibility and technicians/maintenance staff to supplement existing employee base.
Director, Technical Operations
Akorn, Inc
11.2015 - 08.2017
- Responsible for Technical Transfer of new products from R&D to the manufacturing environment, and associated efforts for related Exhibit Batch manufacture. This includes preliminary evaluation of the manufacturing equipment to confirm suitability, as well as immediate oversight of the formulation and filling operations. Required Master Batch Record updates following the manufacturing effort are also completed by the Department. We were also responsible for Manufacturing technical assessments as related to deviations that occurred during routine operation, and associated CAPA’s. This includes machine upgrades, process modifications, and associated activities throughout the facility.
Interim Director, Validation
AIPL
11.2015 - 06.2016
- Responsible for oversight of ongoing validation effort at the Akorn, AIPL (India) validation group. Included hiring of staff, oversight of contract validation support from USA and Europe, and management of local staff. Trained local staff on use of Kaye Validators, wrote SOP’s for operation and report generation. Generated validation plans for Laboratories (Micro and QC) and drafted plans for operations equipment qualification.
Manager, Facilities & Maintenance
Bradbury, Inc
07.2014 - 11.2015
- Responsible for 250,000 sq ft manufacturing facility and associated automated manufacturing equipment. Oversaw expansion of heat treat facility, including introduction of Induction Heat Treatment facility and Cryogenic Freezer.
Director, Validation & Quality Engineering
Akorn, Inc
02.2006 - 07.2014
- Responsible for all Validation and Qualification activities for manufacturing and packaging operations in a USP Injectable Drug environment. Responsible for small group of professionals that write, execute, and create summary reports for all equipment and processes involved in the manufacturing of pharmaceutical products. Also responsible for all Change Control activities, including control systems, equipment repairs, and all process and equipment improvements. Reported to Vice President of Global Quality Assurance.
Senior Manager, Manufacturing Operations
Akorn, Inc
02.2006 - 01.2010
- Responsible for Manufacturing activities associated with the production of pharmaceutical products, in a fast-growing company. Four manufacturing areas, two producing vials, one producing ampules, and one producing ophthalmic bottles. Three formulation areas, each equipped to make bulk solutions, which are filled in one of the aforementioned manufacturing areas. Approximately 75 production employees and 4 supervisors reporting to this position. Started up expansion that had been idle for approximately 6 years. Reported to Vice President of Operations.
Aseptic Technologist
Mallinckrodt Nuclear Imaging, Tyco Healthcare
07.2004 - 02.2006
- Responsible for process engineering activities for aseptic manufacturing of USP injectable drugs. Specified equipment for manufacturing operations and participated in Factory Acceptance Testing as well as qualification of new equipment. Participated in FDA remediation activities and advised senior management of Industry Standards and cGMP. Started up new syringe filling operation and oversaw 2 vial filling operations.
Validation Engineer
Compli, LLC
12.2003 - 07.2004
- Responsible for writing and executing protocols for this validation consulting firm based in Philadelphia, PA. Work was completed for Cardinal Health, located in Raleigh, NC at a start-up location. Sole representative for Compli, LLC on site.
Validation Manager
Houba, Inc
08.2003 - 12.2003
- Responsible for writing and executing protocols for pilot plant equipment and process areas as needed for Active Pharmaceutical Ingredient manufacturing. Houba, Inc announced the termination of all manufacturing operations with their new focus on Research and Development in November, 2003. All personnel were laid off effective December, 2003.
President/Owner
Mid-America Validation Services
12.2001 - 08.2003
- Responsible for writing proposals, ascertaining contracts, and completing the work associated with each contract. The work was performed at Aventis Behring, in Kankakee, IL. The following projects were completed while on site: Edwards Lyophilizer (IQ, OQ, PQ), Filter Press - 4 (IQ, OQ, PQ), Chromatography Skids (IQ, OQ, PQ), Manual Cleaning Validations, Columns (IQ, OQ, PQ), Freezers (IQ, OQ, PQ), Tanks (IQ, OQ, PQ), Mixing Studies, Vial Filling Equipment (IQ, OQ), Packaging Equipment (IQ, OQ)
Validation Engineer
Walthers & Associates
08.2000 - 12.2001
- Responsible for writing and executing protocols for this validation consulting firm based in McPherson, KS. Work was completed for Aventis Behring, located in Kankakee, IL. Tanks (IQ, OQ, PQ), Freezers (IQ, OQ, PQ), Tangential Filters (IQ, OQ, PQ), HVAC Units (IQ, OQ, PQ)
Production Supervisor
Abbott Laboratories
03.1998 - 08.2000
- Responsible for planning and scheduling production activities for aseptic manufacturing of controlled and non-controlled USP injectable drugs. Facilitate packaging operations, maintain production standards, and encourage team building and effective communication development. Responsibilities included, scheduling personnel, annual reviews, interview and hire new personnel, administer operational discipline, and establish financial standards.
Production Equipment Specialist
Abbott Laboratories
03.1994 - 03.1998
- Responsible for maintaining equipment for five different production areas, including 3 filling lines, and 2 inspection and packaging areas. Budget responsibility of $500,000 annually, to be divided between the different areas to best maintain and provide minor machine improvements/upgrades. Recommended major line renovation, and implemented new inspection, labeling, packaging, and final pack operation of $2.5 million for a single dose cartridge area. Supervised 10 Senior Production Operators who were responsible for operating the equipment in the different areas across multiple shifts.
Senior Production Operator
Abbott Laboratories
03.1991 - 03.1994
- Hired to perform maintenance and set-up on third shift for two high speed filling lines, and one packaging area. Took ownership of equipment and assumed responsibility for performing modular rebuilds for TL Bosch equipment. Removed responsibility from maintenance, saving the department money, and freeing the maintenance shop to repair other equipment.
Education
High School -
Marquette High School
Marquette, KS01.1985
Community College - Mechanical Engineering Technology
Hutchinson Community College
Hutchinson, KS01.1986
Skills
- Employee engagement techniques
- Committed team contributor
- Goal-oriented communication
- Proficient in Microsoft Office
- Managing CAPA processes
Timeline
Director, Manufacturing
Rising Pharmaceuticals, Inc
12.2023 - Current
Consultant
Steriqual/NEXA
11.2021 - 12.2023
Commissioning & Qualification Lead (Plant Utilities)
Compli LLC
01.2020 - 11.2021
Plant Manager
BioTechnique/Lyophilization Services of New England
08.2017 - 11.2019
Director, Technical Operations
Akorn, Inc
11.2015 - 08.2017
Interim Director, Validation
AIPL
11.2015 - 06.2016
Manager, Facilities & Maintenance
Bradbury, Inc
07.2014 - 11.2015
Director, Validation & Quality Engineering
Akorn, Inc
02.2006 - 07.2014
Senior Manager, Manufacturing Operations
Akorn, Inc
02.2006 - 01.2010
Aseptic Technologist
Mallinckrodt Nuclear Imaging, Tyco Healthcare
07.2004 - 02.2006
Validation Engineer
Compli, LLC
12.2003 - 07.2004
Validation Manager
Houba, Inc
08.2003 - 12.2003
President/Owner
Mid-America Validation Services
12.2001 - 08.2003
Validation Engineer
Walthers & Associates
08.2000 - 12.2001
Production Supervisor
Abbott Laboratories
03.1998 - 08.2000
Production Equipment Specialist
Abbott Laboratories
03.1994 - 03.1998
Senior Production Operator
Abbott Laboratories
03.1991 - 03.1994
Community College - Mechanical Engineering Technology
Hutchinson Community College
High School -
Marquette High School
Section name
- Manufacturing Management / Supervision – 17 years
- Technical Operations (Process Design/Optimization)
- Quality Engineering/Change Control
- Commissioning of New Construction and/or Facility Upgrades
- Gemba Walk – Safety (regular participant)
- Gemba Walk – Manufacturing Process (Leader)
- Validation Management / Supervision (IQ, OQ, PQ)
- Project Management
- Equipment Specification and Selection
- Extensive Manufacturing Process Knowledge
- Equipment Maintenance/Repair/Upgrade
- Batch Planning / Scheduling