Danielle Clay

Danielle Clay Email and Phone Number

Exec. Director, CMC Operations at BioCryst Pharmaceuticals, Inc. @ BioCryst Pharmaceuticals, Inc.
Danielle Clay's Location
Greater Birmingham, Alabama Area, United States, United States
Danielle Clay's Contact Details

Danielle Clay personal email

n/a
About Danielle Clay

> 20 years of experience in leading product development and CMC teams in a matrixed environment, from IND-enabling studies through POM/POC/pivotal clinical development and NDA/MAA filings.Specialties: CMC strategy and planning, cross-functional team leadership, drug development execution, business development, development of complex injectable drug products, scale-up/process development for clinical manufacturing, CTM supply chain, and biodegradable polymer expertise.

Danielle Clay's Current Company Details
BioCryst Pharmaceuticals, Inc.

Biocryst Pharmaceuticals, Inc.

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Exec. Director, CMC Operations at BioCryst Pharmaceuticals, Inc.
Danielle Clay Work Experience Details
  • Biocryst Pharmaceuticals, Inc.
    Executive Director, Cmc Operations
    Biocryst Pharmaceuticals, Inc. Jan 2022 - Present
    Durham, Nc, Us
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  • Biocryst Pharmaceuticals, Inc.
    Director, Manufacturing & Cmc Operations
    Biocryst Pharmaceuticals, Inc. May 2020 - Jan 2022
    Durham, Nc, Us
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  • Sollis Therapeutics
    Director Program Management
    Sollis Therapeutics Sep 2019 - Apr 2020
    Columbus, Ohio, Us
    View
  • Evonik
    Director, Global Injectable Drug Delivery Services
    Evonik Feb 2016 - Sep 2019
    Essen, Nrw, De
    Provided leadership, strategic direction and tactical oversight for the global business of drug delivery services, for complex parenteral drug products. Responsibilities included business development, technical marketing, strategic budget planning/forecasting, oversight of proposal generation and pricing, and contract negotiation support. Also provided direction and oversight to Global Project Management team to ensure customer programs were executed in accordance with customer expectations.
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  • Takeda Pharmaceuticals
    Cmc Strategy And Program Management
    Takeda Pharmaceuticals Sep 2014 - Feb 2016
    Tokyo, Jp
    Leading global CMC teams and the development of CMC strategy for pipeline assets, while ensuring the defined program scope, budget, and timelines are met with high-quality deliverables. Representing the CMC functional area on cross-divisional governance and development teams, while providing strategy and accountability for CMC deliverables. Additionally, leading the preparation of CMC sections of global regulatory submissions and responses to regulatory agency questions.
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  • Medtronic
    Senior Program Manager, Product Development (Technical Fellow)
    Medtronic Jun 2012 - Sep 2014
    Minneapolis, Mn, Us
    Biologics Therapy Segment Program Management. Responsible for oversight of therapy segment project alignment with global commercialization process and providing updates to key stakeholders and the Project Review Committee.Leadership of cross-functional development teams for pharmaceutical and combination products. Accountable for program plans and strategy, timelines, budgets and resourcing.
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  • Medtronic
    Program Manager, Pharmaceutical Process Development
    Medtronic Jan 2009 - Jun 2012
    Minneapolis, Mn, Us
    Led formulation development, process development, scale up and clinical material supply of pharmaceutical and combination products.
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  • Brookwood Pharma/Surmodics Pharma
    Project Manager Of Product Development
    Brookwood Pharma/Surmodics Pharma Jan 2005 - Jan 2009
    Brookwood Pharmaceuticals is now Evonik Corporation (Birmingham Laboratories).
  • Southern Research Institute
    Research Engineer
    Southern Research Institute Mar 2003 - Jan 2005
    Birmingham, Alabama, Us
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Danielle Clay Skills

Pharmaceutical Industry Drug Delivery Formulation Cross Functional Team Leadership Product Development Fda Pharmaceutical Process Development Process Simulation Clinical Development R&d Controlled Release Medical Devices Pharmaceutical Project Management Combination Products Pharmaceutics Biodegradable Polymers Gmp Regulatory Submissions Program Management Validation Research And Development Microspheres Cmc Cmc Development Process Optimization Extrusion Leading Development Teams Cgmp Manufacturing Polymers Ind Drug Development R Design Of Experiments Technology Transfer

Danielle Clay Education Details

  • University Of Colorado Boulder
    University Of Colorado Boulder
    Chemical Engineering
  • Villanova University
    Villanova University
    Project Management
  • Ohio University
    Ohio University
    Chemical Engineering

Frequently Asked Questions about Danielle Clay

What company does Danielle Clay work for?

Danielle Clay works for Biocryst Pharmaceuticals, Inc.

What is Danielle Clay's role at the current company?

Danielle Clay's current role is Exec. Director, CMC Operations at BioCryst Pharmaceuticals, Inc..

What is Danielle Clay's email address?

Danielle Clay's email address is cu****@****msn.com

What schools did Danielle Clay attend?

Danielle Clay attended University Of Colorado Boulder, Villanova University, Ohio University.

What skills is Danielle Clay known for?

Danielle Clay has skills like Pharmaceutical Industry, Drug Delivery, Formulation, Cross Functional Team Leadership, Product Development, Fda, Pharmaceutical Process Development, Process Simulation, Clinical Development, R&d, Controlled Release, Medical Devices.

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