Process Medical Device

Stephen G. D’Ambrosio, Ph.D.

Principal R&D Scientist

** ***** ****** ***** *****, Etowah, NC 27829; Phone:Home 828-***-****, Cell 732-***-****;

E-mail: ********@***.***

Career Objective: To secure a senior R&D scientist, organic and process development chemist position where I may further advance my technical skills and professional responsibilities.

Education:

Ph.D. 1996 Organic Chemistry, Drexel University, Philadelphia, PA.

Advisor: Professor Peter A. Wade. Thesis: Dihydroisoxazole-Based Synthesis and Polynitrospiropentane related studies.

M.S. 1991 Organic Chemistry, Drexel University, Philadelphia, PA

Advisor: Professor Peter A. Wade.

B.A. 1986 Chemistry, Temple University, Philadelphia, PA. (Four Year Full Scholarship)

Experience:

2008-present: Principal R&D Scientist - R&D, Pisgah Labs: Synthesis and scale-up of pharmaceuticals and pharmaceutical intermediates. Skill in creating improved process development and organic synthesis and pharmaceutical technology formulations and solutions that aid in safe prescription drug use. Representative accomplishments:

Opioid salts and formulations: Successfully developed initial synthesis of various opioid salts and formulations exhibiting anti-abuse and anti-dose dumping properties.

Attention deficit/hyperactivity disorder salts and formulations: Successfully developed initial synthesis of various attention deficit/hyperactivity disorder salts and formulations exhibiting abuse-deterrent and anti-dose dumping properties.

Synthesis and scale-up of pharmaceuticals and pharmaceutical intermediates: Skill in creating improved synthesis, process development and pharmaceutical technology formulations/solutions that aid in safe prescription drug use.

Twenty-one patents and three patent applications to date resulted from above work

2000-2008: Senior Research Chemist - R&D, Chemo Dynamics: Specialty chemical company focused on organic and pharmaceutical intermediates on gram to multi-kilogram scale. Representative accomplishments:

Advanced medical device polymer: Successfully developed synthetic processes for scale up of tyrosine-based monomers and polymers. Managed all (and executed many) activities for transfer to cGMP production under demanding timelines: Quality document and facility preparation, delegation of responsibilities, chemist and technician supervision, etc. High customer confidence in my abilities lead them to engage me for multiple advanced projects.

Thiazolidine-dione multi-step synthesis: Performed Suzuki coupling to obtain high purity product in good yield under cGMP conditions. Because of my established abilities, I was chosen to synthesize one of the key precursors.

Aminobenzamidine scale-up: Successfully scaled-up a three step process involving use of hydrogen chloride and ammonia to provide quality product in kilogram quantities.

Functional excipient synthesis and scale-up: This project was behind schedule without an expectation of success when it was assigned to me. I dedicated many long hours and applied sound process development principles to provide 20 kg in timely fashion.

New catalyst for stereoselective hydrogenation: Invented a process for stereoselectively hydrogenating an aromatic amine to produce the ring hydrogenated counterpart with a high trans/cis ratio at low pressures.

Amide process development: Developed a process for synthesis which eliminated flash chromatography, thereby allowing facile scale-up to produce kilogram quantities.

1997-2000: Research Chemist – R&D, Dixie Chemical Company: Specialty chemical company focused on organic and pharmaceutical intermediates on gram to metric ton scale. Representative accomplishments:

Process improvements for synthesis of n-butyl formyl imidazole (BFI): Developed a scaleable process for the production of BFI on a 20 kg scale. Here, I took on a leadership role for timely success in the scale up process. Additionally, I discovered and demonstrated the efficacy of using recycled oxidizing agent.

Synthesis of NOG-O: Devised a synthetic route to produce high quality NOG-O that exceeded customer expectations. I later successfully scaled up my process even further by a factor of ten.

Process for synthesis of TIC-D: Improved the synthesis process for this anti AIDS intermediate by using decreased catalyst loading for hydrogenation. Furthermore, I demonstrated process efficacy with recycled catalyst.

Process development for cost savings: I developed an economic route for synthesis of both 2-alkylbenzoic acid derivatives in good yield and purity from inexpensive starting materials.

1996: Chemist (Contract Scientist), DuPont Experimental Station, Nylon Intermediates Section. Representative accomplishments:

Synthesis of air-sensitive hydroformylation and hydrocyanation catalysts: Here I was able to establish my credibility and thus worked with great independence.

Publications and References: Available upon request.

Contact this candidate