Steven A. Weissman

Steven A. Weissman Email and Phone Number

Vice President, Head of CMC at Cognition Therapeutics @ Cognition Therapeutics, Inc.
Steven A. Weissman's Location
Short Hills, New Jersey, United States, United States
Steven A. Weissman's Contact Details
About Steven A. Weissman

ORCID iD: https://orcid.org/0000-0001-5358-1193Accomplished CMC/process chemistry leader with small-molecule expertise in API manufacturing and Preclinical Development. Demonstrated proficiency at developing practical chemical processes for early through late-stage clinical candidates and commercial products including Xermelo, Crixivan, Emend and Isentress.Prolific track record of designing and implementing scalable, economical solutions to challenging chemical problems in Research and Manufacturing settings. Led high-performing team of chemists focused on the rapid kg scale-up of intermediates and API's targeted for Pre-clinical studies and Ph I trials, delivering on 35 programs over a 2 year period.Technical expert on drug development teams focused on adhering to project timelines and achieving contracted milestones.Notable Achievements include:Member of Editorial Advisory Board for Organic Process Research and Development (ACS Journal)Inventor on 13 U.S. patentsAuthored over 30 peer-reviewed journal articlesRecipient of the Merck Special Achievement Award: 2007Invited lecturer at eight Universities/CollegesExpertise: Process Optimization ● API Characterization ● Route Selection ● Technology Transfer ● Outsourcing ● High Throughput Screening ● Scale-up ● Design of Experiments ● Green Chemistry Principles ● GMP Manufacturing ● Pre-clinical Development ● Regulatory Compliance ● Project Leadership ● Potent Compound Handling ● Homogeneous Catalysis ● Technical Writing

Steven A. Weissman's Current Company Details
Cognition Therapeutics, Inc.

Cognition Therapeutics, Inc.

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Vice President, Head of CMC at Cognition Therapeutics
Steven A. Weissman Work Experience Details
  • Cognition Therapeutics, Inc.
    Vice President- Head Of Cmc
    Cognition Therapeutics, Inc. Jun 2023 - Present
    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.
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  • Cognition Therapeutics, Inc.
    Executive Director, Head Of Cmc
    Cognition Therapeutics, Inc. Nov 2020 - Jun 2023
    Purchase, New York, Us
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  • Lexicon Pharmaceuticals, Inc.
    Director- Chemical Development
    Lexicon Pharmaceuticals, Inc. Oct 2015 - Sep 2020
    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.
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  • J-Star Research
    Director- Process Chemistry/Qa
    J-Star Research Feb 2013 - Oct 2015
    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.
  • Saw Consulting Llc
    Principal Consultant & Founder
    Saw Consulting Llc Sep 2012 - Feb 2013
    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
  • Concert Pharmaceuticals
    Associate Director-Process Chemistry
    Concert Pharmaceuticals Dec 2009 - Jun 2012
    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.
  • Merck
    Senior Investigator (Process Research)
    Merck 2005 - 2008
    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 >$3M/yr savings upon commercial implementation; Process nominated for 2008 U.S. Presidential Green Chemistry Award
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  • Merck
    Research Fellow/Senior Research Fellow (Manufacturing/ Research)
    Merck 1995 - 2005
    Rahway, New Jersey, Us
    Independently designed, optimized and executed efficient, robust processes for the synthesis of challenging target molecules. Developed robust new methodologies and demonstrate viability on kg-scale. Oversaw technology transfer to pilot plant and manufacturing facilities. Managerial and mentoring responsibility for B.S./M.S. and Ph.D. chemists.• Served critical role on technology transfer team that demonstrated the inaugural Crixivan commercial process. Identified critical process parameters in support of regulatory CMC documentation.• Developed/implemented novel cyclodehydration methodology for piperazinone intermediate; adopted by medicinal chemistry for SAR study. Successfully transferred technology to CRO in support of 200 kg API delivery.• Discovered unprecedented ligand-free aryl cyanation methodology using nontoxic cyanide reagent. Resulting JOC publication cited as top-25 most downloaded article in 2006.• Project leader for NPY-antagonist candidate that delivered intermediates/API in collaboration with Japan-based colleagues using newly-patented ketene chemistry.• Provided influential depositional testimony in support of Simvastatin patent infringement litigation. Resulted in >$ 5 M savings from delay of generic version approval in Canada.
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Steven A. Weissman Skills

Technology Transfer Chemistry Organic Chemistry Drug Development Organic Synthesis Pharmaceutical Industry Design Of Experiments Gmp High Throughput Screening Process Optimization Medicinal Chemistry Outsourcing Drug Discovery Clinical Development Manufacturing Parallel Synthesis Apis Biotechnology Technical Writing Cro Process Simulation Process Chemistry Formulation Cmc Drug Design Pharmaceutics Ind High Performance Liquid Chromatography Api Hplc Lead Change Clinical Trials Characterization Laboratory Fda R&d Quality By Design

Steven A. Weissman Education Details

  • Tufts University
    Tufts University
    Chemistry
  • Rutgers University
    Rutgers University
    Biopharma Innovation
  • University Of Vermont
    University Of Vermont
    Chemistry

Frequently Asked Questions about Steven A. Weissman

What company does Steven A. Weissman work for?

Steven A. Weissman works for Cognition Therapeutics, Inc.

What is Steven A. Weissman's role at the current company?

Steven A. Weissman's current role is Vice President, Head of CMC at Cognition Therapeutics.

What is Steven A. Weissman's email address?

Steven A. Weissman's email address is br****@****ail.com

What schools did Steven A. Weissman attend?

Steven A. Weissman attended Tufts University, Rutgers University, University Of Vermont.

What skills is Steven A. Weissman known for?

Steven A. Weissman has skills like Technology Transfer, Chemistry, Organic Chemistry, Drug Development, Organic Synthesis, Pharmaceutical Industry, Design Of Experiments, Gmp, High Throughput Screening, Process Optimization, Medicinal Chemistry, Outsourcing.

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