Practice Area Focus
- Program Management
- CMC Process Design & Validation
- Regulatory Affairs
- CMC Regulatory Compliance
- Manufacturing Quality Assurance
Mr. Manella joined NDA Partners in 2015 as an Expert Consultant. He is an experienced senior executive with hands-on experience in quality assurance, quality control, regulatory affairs, and manufacturing compliance and has operated in the US, EU and Asian Pacific. His career experience is diverse and includes business turnarounds, startup management, and growth management for pharmaceutical, biotechnology, medical device, nutraceutical, and cosmetics companies.
Mr. Manella was formerly the CEO and President of Coldstream Pharmaceuticals, President and COO of Blaine Pharmaceuticals, VP and Project Director of Beskpack, PLC (Kings Lynn, England), VP and General Manager of ALPharma, and VP and Chief Regulatory Officer at Life Technologies. In his early career, he was the Licensing/New Products Manager at Bristol Myers Squibb, Packaging Manager at Pfizer, Quality Control Laboratory Supervisor at Abbott Laboratories, and a Pilot Plant Chemist at Glaxo Smith Kline.
In one of Mr. Manella’s more notable accomplishments, he pulled 79 ANDAs off the market, then sequentially reintroduced them after negotiating a quality improvement plan with the Baltimore District FDA office with minimal profit loss. He is a certified ISO Lead Assessor and successfully led the effort for ISO 9001 certification in the US, Japan, Scotland and New Zealand for a biotech/in vitro diagnostic company.