Steve Rozell Email & Phone Number

Durham, Nc

Raleigh-Durham, North Carolina Area

Avista Pharma Solutions is Cambrex.

Raleigh-Durham, North Carolina Area

Responsible for the creation, development, implementation and support of LIMS functionality to support end users. By collaborating with our Process chemists, Analytical chemists, QA and other Avista sites, I endeavor to provide a compliant, user friendly LIMS environment.

Raleigh-Durham, North Carolina Area

The Scynexis contract manufacturing, discovery and development and animal health services became part of Avista Pharma Solutions. Avista provides a wide range of services, spanning drug synthesis to drug product manufacturing. www.avistapharma.com.With this transition, I was part of the AR&D team in Durham, focusing on analytical and formulation development, including support of process/manufacturing and analytics project lead support to clients.

Raleigh-Durham, North Carolina Area

"SCYNEXIS, Inc. is a premier drug discovery and development company headquartered in Research Triangle Park, North Carolina. Its scientists have extensive experience in the life sciences industry having, together and individually, been involved in the discovery of innovative medicines over a broad range of therapy areas."As part of the Scynexis team, I support both the company and its clients in supporting internal and external projects, creating and developing analytical methodologies to ensure we provide a quality product.

Nutley, Nj

Part of analytical research and development in Roche. Primarily involved in the development of the methods used for assay, impurity analysis and stability monitoring of both drug substance and drug product from discovery through Phase I clinical trials.

Philadelphia, Pa

Originally PCI Clinical Services, part of Packaging Coordinators, Inc. in Philadelphia. My involvement with PCI Clinical Services was at the point when the building was a shell. I worked closely with Clinical Operations and Clinical Supplies Management, Corporate Quality and the construction crews in the design and construction of the facility. I revised all existing quality systems to ensure tighter levels of compliance for the clinical packaging and manufacturing areas within the facility; including the development of validation plans, designing, equipping and staffing chemistry and microbiology laboratories, developing control systems for receipt and management of Schedule II drug (I was acting attorney-in-fact for the facility). Essentially, as a manager in a small start up group, it was a requirement to find a rapid and quality solution to any and all problems that arise in the creation of a new facility. Eventually, that responsibility included hosting the audits of prospective clients, ensuring client confidentiality, and providing agile, effective response to client concerns.

Holopack is a blow-fill-seal contract manufacturer in Columbia, SC. I was employed when the facility was finishing construction and began startup operations. I was heavily involved in the validation of facility systems, initiating environmental monitoring, protocol writing for Chemistry, Microbiology and Metrics laboratories.

When Aventis was Hoechst Roussel Pharmaceuticals, Inc., I was employed as a research scientist, where I was proficient in HPLC, UV/Vis, GC, DSC/TGA, and worked on developing methodology primarily for solid oral dosage forms and creams/ointments.