Manager Engineer

Brian Johnson

*********@*****.*** **** White Circle Jonesboro AR 72404 870-***-****

Qualification Summary

Current Research, Development, and Compliance Manager: adaptable, analytical, and efficient manager with 16+ years’ experience formulating products and managing production in an FDA controlled industry. Excellent personal and digital communication skills.

Education

Lyon College

1990-1994 Major in Chemistry

Professional Development Classes

2004 Tablet and Capsule manufacturing

2005 Tablet Press set-up, tooling, and tooling rework

2009 Tablet Pro for Nutritional Manufacturing

2009 5 Mistakes companies make during an FDA inspection

2009 Preparing for your first FDA inspection

2013 21 CFR 111 Dietary Supplement GMP overview

2014 FDA Inspections and Emerging issues for dietary supplements

Experience

Lifeplus 45 Shirrell Lane Batesville AR 72501

Quality Assurance Analyst 1999 – 2002

Responsible for performing wet chemistry analysis of Rx fluoride products for dental offices. Calibrated instruments. Implemented and controlled stability studies of Rx fluoride products.

Formulation Chemist/Process Engineer 2002– present

Formulated new dental products and continue to formulate new dietary supplements. Conduct test batches for product improvement. Plan test batches and delegate tasks to production. Spearhead and integrate plans for new processing equipment and procedures that increase output and efficiency.

Production Manager 2007 – 2013

Orchestrated day to day operation of production lines and employees. Assisted with long term and short term planning of both production scheduling and production staffing.

Research, Development, and Compliance Manager 2013 – present

Leading the formulation team for new vendor and raw material approvals. Periodically conducting vendor audits. Coordinating stability studies to determine BBE dates. Harmonizing raw material specs with raw material analysis reports. Reviewing labels to assure compliance with food and/or supplement regulations in both the US and EU. Initiating and writing updates to documents: batch records, SOPs, specifications and test methods, ensuring documents comply with 21 CFR 111. Coordinating new product launches: formulating new products from base formulation, develop specs and testing for new materials, coordinate approval of ingredients and packaging, and prepare master batch records. Involved in internal audits and completion of CAPAs. Involved in failure investigations. Member of product recall team. Develop and write process deviations. Assist in manufacturing supervision and other duties as required.

Skills

Highly skilled in Microsoft Excel and Word

Daily use of MRPs (Infor, Fourth Shift, Vantage)

Hands on experience with manufacturing, packaging, and testing equipment

Can head, organize, and drive a team to successfully complete projects

Contact this candidate