Director, Drug Product Development

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. 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 www.biocryst.comor follow uson LinkedInand Instagram.

JOB SUMMARY:

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide scientific, technical and operational leadership for formulation, process development and manufacturing of patient-centered, injectable drug products for BioCryst's portfolio from pre-clinical to successful licensure, primarily through external partners.
• Develop drug productdevelopmentstrategies through internal/external partnerships and product integration into drug/device combination products.
• Enablethe progression of BioCryst's biologics portfoliothatcurrently includes protein-based modalities asliquid and lyophilized dosage forms in vial, prefilled syringe, and cartridge-based presentations.
• Drive the product development efforts in a phase-appropriate manner defining formulation, manufacturing process, container/closure for clinical trials and towards commercialization.
• Lead interactions with external partners to drive the above activities. Maintain close collaboration with internal program leaders and stake-holders.
• Support organization and program leaders in developing budgets, timelines, tracking progress as well as risk identification, communication and mitigation.
• Provide subject matterexpertisefor technical due diligence and for the technical as well as strategic content of the relevant drug product sections of regulatory submissions.
• Author and review highquality development reports, technical summaries and other documentation to support product development.
• Mentorand developcolleagues to internal and matrix teams, contributing to a high-performing pharmaceutical sciences organization.
• Stay current with evolving CMC and global regulatory strategies for biologics and smallmolecule programs through literature and external networking, ensuring alignment with industry best practices and regulatory expectations.
• Performs other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• MS / PhD in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with at least 10 years of relevant field experiencein end-to-end biologics drug product development (encompassing formulation, process development, scale up,technologytransferand manufacturing support). A significant part of this experience must include directing and managing development with external partners.
• Must be proficient in current approaches for formulation and drug product process development, manufacturing processes and equipment,regulatory expectationsand applying these to developing efficient approaches to ensure product licensure.
• Experience with high concentration protein formulation development, aseptic processes, vial, prefilled syringe, cartridge presentations,liquid and lyophilization dosage forms is a must.
• Knowledge of current regulatory guidelines and cGMP requirements is necessary.
• Must have a strong grounding in biochemistry / biophysics to ensure a science-driven approach to biologics product development.
• Demonstrated experience supporting regulatory submissions and interacting with Analytical, Quality and Regulatory functions.
• Proven ability to manage external partners and deliver results in a fastpaced biotech environment.
• Excellent written and verbal communication skills, including experience authoring technical reports and regulatory documentation.

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

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