Steven A. Weissman Email & Phone Number

Purchase, New York, Us

Department head responsible for the drug substance/drug product development and GMP manufacture of clinical candidate, CT1812. Member of Executive committee.

Purchase, New York, Us

The Woodlands, Tx, Us

Responsible for commercial manufacturing of telotristat etiprate (Xermelo) drug substance at international CMOs. Drug substance technical steward on Xermelo Commercial Supply Chain team. CMC administrator for Veeva document management system. Authored CMC sections of IND filings. Coordinated logistics of commercial API and R&D shipments to vendors world-wide. Scientific lead for PhI candidates.

Research Director providing technical and project leadership to clients for process development and manufacture of clinical trial drug substance. Manage the timely technology transfer of internally-developed processes to commercial CMOs. Advise clients on process optimization and characterization strategies, including PAR studies through DoE investigations to facilitate regulatory filings.Reviewed/approved drug substance stability protocols/reports, SOPs, batch records and instrumentation IQ/OQ documents. Maintained company training records and approved supplier list. Completed software validation of VAISALA stability chamber monitoring system.

Provided process chemistry advisory services to pharmaceutical companies and contract research providers.Expertise:• Process development aimed at scale-up• Outsourcing : CRO vetting; project management; Technology transfer• Route selection• Statistical Design of Experiments (DoE)• Technical documentation: CMC-related (IND, NDA)• Manufacturing troubleshooting; implementing solutions• cGMP manufacturing of API/intermediates

Process Chemistry leader focused on developing IND-enabling routes to deuterated drug candidates. Point of contact for all contract vendor interactions including vendor vetting, selection and relationship management. Managed the tech transfer, manufacturing and drug substance release in support of Phase I/II trials. Aligned CMC activities with research, preclinical, analytical and regulatory groups. Responsible for all API supplies to support safety, drug development and CTM for multiple programs.

Rahway, New Jersey, Us

Synthesis Support Group (Team Leader): Directed and conducted the rapid lab development of scalable chemical processes followed by timely delivery of multi-gram to kg amounts of API/intermediates in support of safety assessment, formulation development and Phase I trials under GMP conditions. Coordinated resources and communicated results with project customers to maximize efficiency and ensure adherence to project timelines.• Successfully managed 4 chemists during period of rapidly escalating project load (over 33 programs supported).• Reduced time cycles and delivery costs by 20% by partnering with Procurement to identify preferred vendors, reducing development time cycles and raw material overages, and effective risk management.• Honored with prestigious Merck Special Achievement award for concurrent project leadership on 2 high-profile, fast-tracked clinical programs.• Elevated selectivity of Isentress methylation chemistry from 77 to 99% resulting in >$3M/yr savings upon commercial implementation; Process nominated for 2008 U.S. Presidential Green Chemistry Award

Rahway, New Jersey, Us

Independently designed, optimized and executed efficient, robust processes for the synthesis of challenging target molecules. Developed robust new methodologies and demonstrate viability on kg-scale. Oversaw technology transfer to pilot plant and manufacturing facilities. Managerial and mentoring responsibility for B.S./M.S. and Ph.D. chemists.• Served critical role on technology transfer team that demonstrated the inaugural Crixivan commercial process. Identified critical process parameters in support of regulatory CMC documentation.• Developed/implemented novel cyclodehydration methodology for piperazinone intermediate; adopted by medicinal chemistry for SAR study. Successfully transferred technology to CRO in support of 200 kg API delivery.• Discovered unprecedented ligand-free aryl cyanation methodology using nontoxic cyanide reagent. Resulting JOC publication cited as top-25 most downloaded article in 2006.• Project leader for NPY-antagonist candidate that delivered intermediates/API in collaboration with Japan-based colleagues using newly-patented ketene chemistry.• Provided influential depositional testimony in support of Simvastatin patent infringement litigation. Resulted in >$ 5 M savings from delay of generic version approval in Canada.

Phd, Chemistry

Mini-Mba, Biopharma Innovation

Ba, Chemistry