Dave Brown

About Dave Brown

I am a scientist and program manager with an expertise in pharmaceutical, nutraceutical and coated medical device R&D. Creativity and exploration are the tools I use to get new products to market, utilizing my core strengths of innovation, product development, process scale-up, cGMP documentation, and problem solving. My strong background in quality assurance, process validation, FDA submissions, and product testing allows me to work cross functionally for success and I adhere to the project management principles of PMBOK. Whether working with immediate release, controlled release, effervescent or oral fast dissolve tablets, I have created successful commercial products for both prescription and over-the-counter markets. I use a combination of detailed observation, designed experiments and an excellent working relationship with operations and engineering staff to achieve results. Seeking out process improvement opportunities to reduce equipment down time, increase yields and improve process flow energizes me. My leadership style is empowering and I make a point to lead by example. I insist on effective cross-functional teamwork and dedication to the task at hand. Keeping my team accountable for their actions, while making a point of recognizing hard work is critical. I believe that people should be provided with the resources to be successful and assigned tasks that will stretch their abilities.Specialties: Solid, liquid, semi-solid and nasal drug delivery, including controlled, delayed and immediate release products (plus fast dissolve tablets). Areas of specialty also include drug/polymer coating, particle size reduction, blending/mixing/pneumatic conveying, compression/bottling/blistering and secondary packaging. I have significant experience in project management, quality investigations, regulatory submission documents, customer relations and managing a range of scientists/engineers.

Experience

1. Manager, Validation

   Takeda

   Mar 2021 — Present · Brooklyn Park, MN, US

   Responsible for all validation activities related to cleaning and sterilization processes at the site. Heavily involved in change control activities and supporting any investigation/CAPA work as needed.

Education

• The University of Manchester

  Masters, Industrial Pharmaceutical Sciences

  1993 — 1998

Skills

• Medical Devices
• Capa
• Pharmaceuticals
• Formulation
• Validation
• Analytical Chemistry
• Project Management
• Cmc Regulatory Affairs
• Cross-Functional Team Leadership
• Six Sigma
• Product Launch
• Gmp
• Pharmaceutics
• Iso 13485
• Quality Assurance
• Lean Manufacturing
• Drug Delivery
• Coatings
• Regulatory Submissions
• Formulation Development
• Commercialization
• R&D
• Hplc
• Quality System
• V&V
• Process Simulation
• Design of Experiments
• Manufacturing
• Pharmaceutical Industry
• Sop
• Fda
• Process Improvement
• 5s
• Product Development
• Technology Transfer