Stephen D'Ambrosio Email & Phone Number

Princeton, Nj, Us

Princeton, Nj, Us

South Plainfield, New Jersey, United States

Proven leadership with management of other chemists and day-to-day operations in GMP and GMP HPAPI. Experience in GMP scale-up, writing GMP batch records, SOP’s and deviation reports. Conduct research in a laboratory setting in support of GMP projects, Coordinate with management, the Analytical Department, the client, and others on issues concerning experiments prior to and during GMP production, Write batch records for use in the production of intermediates and API in a GMP environment… Show more Proven leadership with management of other chemists and day-to-day operations in GMP and GMP HPAPI. Experience in GMP scale-up, writing GMP batch records, SOP’s and deviation reports. Conduct research in a laboratory setting in support of GMP projects, Coordinate with management, the Analytical Department, the client, and others on issues concerning experiments prior to and during GMP production, Write batch records for use in the production of intermediates and API in a GMP environment, Supervise the writing of batch records for use in the production of intermediates and API in a GMP environment and provide feedback and recommendations as needed, Supervise the execution of batch records in the production of API and/or intermediates in the cGMP environment to insure that SOP's are followed and regulations met, Train GMP Personnel on aspects of writing batch records consistent with relevant SOP's, Write research and campaign reports related to current projects as required. Show less

South Plainfield, Nj

Synthesis and scale-up of pharmaceuticals and pharmaceutical intermediates. Skills in creating improved process development and organic synthesis that allow efficient processes for kilogram to multi-kilogram scale. Experience in GMP scale-up and writing GMP batch records, SOP’s and deviation reports.

Synthesis and scale-up of pharmaceuticals and pharmaceutical intermediates. Skill in creating improved process development and organic synthesis of API’s and pharmaceutical technology formulations in GMP environment 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… Show more Synthesis and scale-up of pharmaceuticals and pharmaceutical intermediates. Skill in creating improved process development and organic synthesis of API’s and pharmaceutical technology formulations in GMP environment 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.• Multiple patents resulted from above work Show less

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… Show more 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. Show less

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 40% less oxidizing agent. • Synthesis of NOG-O: Devised a synthetic route to… Show more 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 40% less 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. Show less

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.

Doctor Of Philosophy - Phd, Organic Chemistry

Bachelor Of Arts - Ba, Chemistry

Master Of Science - Ms

H.S.

Bachelor Of Arts - Ba