Samuel Conway Email & Phone Number

Raleigh-Durham, North Carolina Area

Still in the field of extractables and leachables, just now for BD Technologies. My role is primarily in medical device R&D. I work alongside the product engineers to help them understand how changes, even very trivial ones, can affect the interaction of a packaging or delivery system with a drug product. I primarily have my hands on LCMS and GCMS instruments, including an absolutely gorgeous high-resolution Thermo GCMS.

Wilmington, North Carolina Area

After a stint in Formulation Development, I was asked to head up to the Extractables and Leachables team at Alcami. My job involves oversight of all phases of E&L projects, from initial consultation with the client to study design to execution to data evaluation and reporting. Fortunately, I have inherited a great team of scientists, who together can accomplish just about any miracle that a client could ask from us.

Wilmington, North Carolina Area

Consultant for CMC Submissions. I lend expertise to clients in the fields of document preparation, data review and interpretation, and regulatory requirements. I also serve as a Subject Matter Expert for Extractables and Leachables studies, and increasingly have been responsible for revenue projections and resource allocation.

Research Triangle Area, Nc

I was responsible for extractables/leachables studies for pharmaceutical packaging from initial material characterization to final testing of product under cGMP. After three years of service, I was given responsibility for all projects involving identification of unknown leachables, where my background in organic chemistry was quite useful. The position involved direct customer contact at all phases of study, including method development and validation. The size of the group was fluid, but at its height I supervised one lead scientist, one scientist, and two associate scientists. During my tenure at Catalent I authored more than 100 technical studies, introduced a novel extraction technique that reduced analyst bench-time by more than 60% and waste disposal costs by more than 90%, and introduced and managed a new site emergency alert and response system.

Exton, Pa

West is primarily a manufacturer of rubber stoppers, but it also provides analytical services to outside companies on a contract basis to satisfy FDA requirements for monitoring extractables and leachables from pharmaceutical packaging. Here I gained expertise in all matters related to the evaluation of extractable/leachable components from pharmaceutical packaging systems, including analytical method development and validation under cGMP. The position involved direct customer contact at all phases of study. After a year, the group leader departed and I found myself supervisor of one principal chemist, three senior chemists and one laboratory technician. During my time at West I authored more than 200 technical studies, and within ten months of taking over the E&L group managed to increase project revenue by 75%. I also created and maintained a searchable database of all E&L studies as a tool to facilitate method development and validation.

Greater Philadelphia Area

Cerexagri was the agrichemical division of Atofina (now Arkema) Chemicals, prior to its divestiture. I was responsible for maintenance of product registrations, including conduct of all product chemistry studies under 40 CFR Part 158 (Subpart D). My duties evolved to include hands-on QC analysis of finished products and synthesis of radiolabeled targets for environmental fate studies. During this time, digitization was just coming into its own. After dealing for several months with stacks of paper, I created and maintained a searchable database of inert ingredients, including major properties and current regulatory status, and also created automated CSF (Confidential Statement of Formula) generator and moved all CSF’s from paper to electronic format.

Ph.D., Chemistry

Activities and Societies: Dartmouth Handel Society, Dartmouth Japan Society

Bs, Chemistry

Activities and Societies: Ursinus Meistersingers, Beardwood Chemical Society, Pi Nu Epsilon