Jared Randall

Jared Randall Email and Phone Number

Senior Director Chemistry, Manufacturing and Controls @ Invirsa, Inc
Jared Randall's Location
Smyrna, New York, United States, United States
Jared Randall's Contact Details

Jared Randall personal email

n/a
About Jared Randall

Pharmaceutical and chemical industry expert with extensive experience in a broad range of molecular classes and development activities from discovery through commercialization of Active Pharmaceutical Ingredients (APIs). Known for in-depth knowledge of chemical process development, sourcing, technical due diligence and intellectual property. Strong track record of innovation in developing efficient, practical and cost-effective chemical processes. Successfully builds and integrates high-performance R&D teams, and effectively collaborates with multi-disciplinary project teams to efficiently advance development programs.Specialties:Chemical Process Development | Drug Substance | API | CMC | Outsourcing | Vendor Selection | Project Management | Solid State and Polymorph Studies | Technical Due Diligence | ICH | FDA | EMEA website: www.pharmachemica.com email: pharmachemica@frontier.com

Jared Randall's Current Company Details
Invirsa, Inc

Invirsa, Inc

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Senior Director Chemistry, Manufacturing and Controls
Jared Randall Work Experience Details
  • Invirsa, Inc
    Senior Director Of Chemistry, Manufacturing And Controls
    Invirsa, Inc Nov 2023 - Present
    Smyrna, New York, United States
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  • Pharmachemica Cmc Consulting Llc
    Principal
    Pharmachemica Cmc Consulting Llc Jun 2010 - Nov 2023
    Sherburne, Ny
    Provides consulting services to the pharmaceutical, chemical and related industries. Catalyzes product development in the areas of:- Synthetic route design and process development.- Sourcing and management of chemical process development and scale up activities at CROs/CMOs.- Sourcing and management of analytical and formulation development activities at CROs/CMOs.- Evaluating quality assurance and regulatory compliance.- Technical due diligence support.- Business development
  • Aerpio Pharmaceuticals
    Director Of Development Chemistry
    Aerpio Pharmaceuticals Jun 2019 - Jun 2021
    Sherburne, Ny
    A part-time consulting role- Responsible for drug substance process development for Aerpio Pharmaceuticals' lead compounds- Leads drug substance process development activities at CMOs/CROs- Leads drug substance vendor evaluation and selection- Negotiates contracts and master service agreements (MSAs) with vendors- Troubleshoots drug substance synthetic processes- Leads solid state and polymorph studies- Collaborates with internal and external analytical resources to identify impurities and develop understanding of formation and purging - Authors drug substance sections of regulatory submissions- Compiles drug substance information for technical due diligence by potential investors and partners
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  • Aerpio Pharmaceuticals
    Director Of Development Chemistry
    Aerpio Pharmaceuticals Aug 2017 - May 2019
    Cincinnati Area, Ky
    Employee
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  • Aerpio Therapeutics, Inc.
    Director Of Chemistry
    Aerpio Therapeutics, Inc. Jul 2016 - Jul 2017
    Cincinnati Area, Ky
    A part-time consulting role
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  • Kinnear Pharmaceuticals
    Director Of Cmc
    Kinnear Pharmaceuticals Jun 2015 - May 2017
    Columbus, Ohio Area
    A part-time consulting role- Responsible for drug substance process development for Kinnear Pharmaceuticals' lead compounds- Led drug substance process development activities at CMOs/CROs- Led drug substance vendor evaluation and selection- Negotiated contracts with vendors- Troubleshooting of drug substance synthetic processes
  • N8 Medical, Inc.
    Director Of Cmc And Process Development
    N8 Medical, Inc. Jan 2013 - May 2017
    Columbus, Ohio Area
    A part-time consulting role- Responsible for drug substance process development for N8 Medical's lead compounds- Led drug substance process development activities at CMOs/CROs- Led drug substance vendor evaluation and selection- Negotiated contracts with vendors- Troubleshooting of drug substance synthetic processes- Led solid state and polymorph studies- Collaborated external analytical resources to identify impurities and develop understanding of formation and purging - Authored drug substance sections of regulatory submissions
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  • Procter & Gamble
    Principal Scientist
    Procter & Gamble Jun 1995 - Sep 2012
    Norwich, Ny
    API Sourcing and Technical Due Diligence Worked with multi-disciplinary technical due diligence team as API Leader for pharmaceutical licensing and acquisition opportunities, including small molecule, peptide and biologic APIs. Evaluated and selected Contract Manufacturing Organizations (CMOs) for sourcing of APIs and chemical intermediates for all development programs.Chemical Development Project Leader Led development programs for a number of APIs in diverse chemical classes, including heterocycles, prostaglandins, steroids and synthetic peptides. Represented Chemical Development on project “Core Teams” for a number of development programs with diverse therapeutic indications, including anti-inflammatory, cardiac, osteoporosis, muscle wasting, migraine, and decongestant therapies.Intellectual Property Development Program LeaderLed multi-disciplinary teams to develop strategies to enhance company intellectual property.Health, Safety and Environment (HS&E) Managed environmental remediation activities at the Norwich, NY site, collaborating with environmental consultants, contractors and regulatory agencies. Led site HS&E program and managed HS&E personnel for pharmaceutical development activities.
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  • Procter & Gamble
    Senior Scientist
    Procter & Gamble Dec 1991 - Jun 1995
    Norwich, Ny
    Process R&D for APIs for bone, anti-inflammatory, cardiac, and anti-migraine therapies.
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  • Procter & Gamble
    Scientist, Drug Discovery
    Procter & Gamble Jun 1986 - Dec 1991
    Cincinnati, Ohio Area
    Designed and led drug discovery research programs for anti-microbial and gastrointestinal therapies.
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Jared Randall Skills

Drug Discovery R&d Pharmaceutical Industry Technology Transfer Organic Chemistry Gmp Commercialization Drug Development Fda Organic Synthesis Pharmaceutics Regulatory Submissions Life Sciences Chemistry Process Simulation Biotechnology Medicinal Chemistry Hplc Glp Analytical Chemistry Chromatography Lifesciences Regulatory Affairs Validation Clinical Development Cro Cmc Intellectual Property Formulation Research And Development Technical Due Diligence Drug Delivery Lc Ms Biopharmaceuticals Toxicology Chemical Processing Laboratory Good Laboratory Practice High Performance Liquid Chromatography Product Development Sop Management Cross Functional Team Leadership

Jared Randall Education Details

Frequently Asked Questions about Jared Randall

What company does Jared Randall work for?

Jared Randall works for Invirsa, Inc

What is Jared Randall's role at the current company?

Jared Randall's current role is Senior Director Chemistry, Manufacturing and Controls.

What is Jared Randall's email address?

Jared Randall's email address is jr****@****pio.com

What schools did Jared Randall attend?

Jared Randall attended University Of Pennsylvania, University Of South Florida, Hamilton College.

What are some of Jared Randall's interests?

Jared Randall has interest in Api, Technical Due Diligence, Intellectual Property, Chemical Development, Cmc.

What skills is Jared Randall known for?

Jared Randall has skills like Drug Discovery, R&d, Pharmaceutical Industry, Technology Transfer, Organic Chemistry, Gmp, Commercialization, Drug Development, Fda, Organic Synthesis, Pharmaceutics, Regulatory Submissions.

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