Executive Director, Cmc Operations
Current
Jan 2022 - Present
AeroLeads people directory · profile
Danielle Clay Email & Phone Number
Exec. Director, CMC Operations at BioCryst Pharmaceuticals, Inc.
at
BioCryst Pharmaceuticals, Inc.
1 work email found
@biocryst.com
LinkedIn matched
✓ Verified August 2026
4 data sources
Profile completeness 100%
Current company
Role
Exec. Director, CMC Operations at BioCryst Pharmaceuticals, Inc.
Location
Greater Birmingham, Alabama Area, United States
Who is Danielle Clay? Overview
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Quick answer
Danielle Clay is listed as Exec. Director, CMC Operations at BioCryst Pharmaceuticals, Inc. at BioCryst Pharmaceuticals, Inc., based in Greater Birmingham, Alabama Area, United States. AeroLeads shows a work email signal at biocryst.com and a matched LinkedIn profile for Danielle Clay.
Danielle Clay previously worked as Executive Director, CMC Operations at Biocryst Pharmaceuticals, Inc. and Director, Manufacturing & CMC Operations at Biocryst Pharmaceuticals, Inc.. Danielle Clay holds Phd, Chemical Engineering from University Of Colorado Boulder.
Company email context
Email format at BioCryst Pharmaceuticals, Inc.
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{first_initial}{last}@biocryst.com
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Profile bio
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.
Listed skills include Pharmaceutical Industry, Drug Delivery, Formulation, Cross Functional Team Leadership, and 30 others.
Current workplace
Danielle Clay's current company
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9 roles
Danielle Clay work experience
A career timeline built from the work history available for this profile.
Director, Manufacturing & Cmc Operations
May 2020 - Jan 2022
Director Program Management
Sep 2019 - Apr 2020
Director, Global Injectable Drug Delivery Services
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.
Feb 2016 - Sep 2019
Cmc Strategy And Program Management
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.
Sep 2014 - Feb 2016
Senior Program Manager, Product Development (Technical Fellow)
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.
Jun 2012 - Sep 2014
Program Manager, Pharmaceutical Process Development
Led formulation development, process development, scale up and clinical material supply of pharmaceutical and combination products.
Jan 2009 - Jun 2012
Project Manager Of Product Development
Brookwood Pharma/Surmodics Pharma
Brookwood Pharmaceuticals is now Evonik Corporation (Birmingham Laboratories).
Jan 2005 - Jan 2009
Research Engineer
Mar 2003 - Jan 2005
3 education records
Danielle Clay education
Phd, Chemical Engineering
University Of Colorado Boulder
Master'S, Project Management
Villanova University
Bs, Chemical Engineering
Ohio University
FAQ
Frequently asked questions about Danielle Clay
Quick answers generated from the profile data available on this page.
What company does Danielle Clay work for?
Danielle Clay works for BioCryst Pharmaceuticals, Inc..
What is Danielle Clay's role at BioCryst Pharmaceuticals, Inc.?
Danielle Clay is listed as Exec. Director, CMC Operations at BioCryst Pharmaceuticals, Inc. at BioCryst Pharmaceuticals, Inc..
What is Danielle Clay's email address?
AeroLeads has found 1 work email signal at @biocryst.com for Danielle Clay at BioCryst Pharmaceuticals, Inc..
Where is Danielle Clay based?
Danielle Clay is based in Greater Birmingham, Alabama Area, United States while working with BioCryst Pharmaceuticals, Inc..
What companies has Danielle Clay worked for?
Danielle Clay has worked for Biocryst Pharmaceuticals, Inc., Sollis Therapeutics, Evonik, Takeda Pharmaceuticals, and Medtronic.
How can I contact Danielle Clay?
You can use AeroLeads to view verified contact signals for Danielle Clay at BioCryst Pharmaceuticals, Inc., including work email, phone, and LinkedIn data when available.
What schools did Danielle Clay attend?
Danielle Clay holds Phd, Chemical Engineering from University Of Colorado Boulder.
What skills is Danielle Clay known for?
Danielle Clay is listed with skills including Pharmaceutical Industry, Drug Delivery, Formulation, Cross Functional Team Leadership, Product Development, Fda, Pharmaceutical Process Development, and Process Simulation.
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