VP, MS&T

COMPANY:

At BioCryst, 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, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina 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 www.biocryst.com or follow uson LinkedInand Instagram.

JOB SUMMARY:

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide enterprise-level leadership for MS&T across the company's portfolio, aligning technical execution with strategic growth objectives and ensuring readiness for scale-up, new product introductions, and increased manufacturing complexity.
• Lead MS&T strategy and operations for both biologics and small molecule programs from late clinical development through regulatory submissions, initial licensure, and commercial launch.
• Oversee all technical aspects of external manufacturing, including process development, process validation, technology transfer, and routine technical support for the external manufacturing network.
• Serve as the primary MS&T lead in health authority interactions (FDA, EMA, and other global agencies), owning and representing manufacturing strategies, control rationale, and lifecycle plans.
• Direct the preparation, review, and defense of CMC regulatory submissions (INDs, BLAs, MAAs, briefing packages, Module 3 content) and ensure scientific rigor and regulatory defensibility.
• Partner cross-functionally with Process Development, Analytical Development, Quality, Regulatory Affairs, Commercial Operations, and Manufacturing & Supply to ensure end-to-end technical and regulatory alignment.
• Design and implement operating models, governance structures, and talent strategies to scale the MS&T function for 2-5x organizational growth, including organizational design, recruitment, retention, and leadership development.
• Establish and embed risk management frameworks consistent with ICH Q8/Q9/Q10, Quality by Design, and current regulatory expectations, ensuring robust process control and proactive risk anticipation.
• Identify and implement industry best practices and technical innovations in process validation, technology transfer, and process optimization for both biologics and small molecule products.
• Oversee data tracking and trending programs to monitor process performance, support data-driven decision-making, and ensure compliance with quality and regulatory standards. (Move to QC JD's ?)
• Support the preparation and review of technical and manufacturing documentation (e.g., protocols, process descriptions, batch records, SOPs, technical reports) and interface with internal/external QA and QC groups.
• Build and sustain employee engagement and a culture of efficient execution, continuous improvement, and technical excellence.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Degree Requirements. or an equivalent combination of education and experience.
• Bachelors degree required in biochemical engineering, chemical engineering, pharmaceutical sciences, biotechnology, or a closely related discipline with a Masters or PhD preferred
• 15+ years of experience in the biopharmaceutical industry, including at least 10+years in biologics development (e.g., monoclonal antibodies, recombinant proteins) and 5+ years in small molecule/solid oral dosage development.
• Demonstrated leadership of MS&T or Technical Development functions supporting original BLA submissions (not supplements only).
• Proven ownership of CMC regulatory strategy, including authorship, defense, and lifecycle management of regulatory submissions (IND, BLA, MAA).
• Extensive experience in upstream, downstream, and/or drug product development, process validation, technology transfer, and external manufacturing management.
• Documented experience scaling technical organizations through periods of rapid growth (2-5x), including organizational design, talent development, and governance.
• Deep understanding of biologics and small molecule manufacturing processes, control strategies, and regulatory requirements.
• Excellent planning, organization, and management skills, with the ability to direct internal teams and external collaborators.
• Strong critical thinking, problem-solving, and communication skills, with demonstrated ability to interface at all organizational levels and with external contract organizations.
• Results-oriented, with strong initiative, accountability, and a sense of urgency.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.