VP, Drug Substance

## VP, Drug Substance Apply:
US _North Carolina _Remote:
US _Massachusetts _Boston Office:
Full time:
Posted 6 Days Ago:
JR100203
** COMPANY:
*** At Bio Cryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases.
* * We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries.
* * We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at
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* JOB SUMMARY:

**  ### The Vice President, Drug Substance is responsible for enterprise drug substance strategy and execution across Bio Cryst’s small-molecule and biologics portfolio. The role provides end-to-end leadership for drug substance process and technology development, scale-up, manufacturing readiness, technology transfer, process characterization and validation, and commercialization. This leader ensures that phase-appropriate, robust, compliant, and commercially viable drug substance processes are advanced in alignment with program objectives and global regulatory expectations.  

### As the senior functional leader for Drug Substance, the Vice President will shape the function’s strategy, organizational capabilities, externalization model, resource plan, and technology roadmap. The role partners closely with Analytical Development, Drug Product Development, MS&T, Quality, Regulatory, Global Manufacturing and Supply Chain, while serving as the primary technical leader for external drug substance development and manufacturing partners.  #
** ESSENTIAL DUTIES & RESPONSIBILITIE
** S:  
*** Drug Substance Strategy and Portfolio Leadership**
* · Own and execute the drug substance strategy across small-molecule active pharmaceutical ingredients and biologic drug substances, from candidate selection and early development through late-stage development, validation, launch readiness, commercialization, and lifecycle management.
· Align drug substance priorities, deliverables, timelines, budgets, and resources with portfolio and corporate objectives; identify critical dependencies and escalate risks with clear mitigation plans.
· Create, maintain, and curate the drug substance technology roadmap to guide platform capabilities, process innovation, digitalization strategies, externalization strategy, capacity planning, and investment priorities.
· Provide drug substance leadership in program teams, portfolio reviews, due diligence, regulatory interactions, indication expansion assessments, and technology or innovation evaluations; collaborate with Analytical Development and Drug Product Development to ensure integrated CMC strategies and aligned program execution.  
*** Process Development, Scale-Up, and Commercial Readiness**
* · Oversee phase-appropriate process development and manufacturing readiness, including biologics cell line and upstream and downstream process development, and small-molecule route, process, and control-strategy development.
· Provide technical oversight for scale-up, process characterization, process validation readiness, process performance qualification, technology transfer, and manufacturing support. Lead drug substance clinical-supply strategy and execution through pivotal clinical development and collaborate with MS&T and Global Manufacturing and Supply after validation to support commercialization,…