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.com or follow us on LinkedIn and Instagram.
JOB SUMMARY:
The Director of Drug Product Development will lead and direct formulation and process development for patient-centered parenteral drug products supporting BioCryst’s biologics portfolio. This role is responsible for development of portfolio projects in a phase‑appropriate manner while working with external Contract Development and Manufacturing Organizations (CDMOs). The role involves responsibility for all aspects of biologics drug product development from supporting early discovery efforts to late-stage technology transfer, scale-up, process validation and commercialization.
The incumbent will work cross‑functionally with other groups outside the Pharmaceutical Sciences organization, including Clinical Operations, Quality, & Device Development, to support clinical and late‑stage development programs. This position requires strong and comprehensive scientific and technical expertise in biologics product development and the ability to operate effectively in a fast‑paced, collaborative biotech environment.
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 product development strategies through internal/external partnerships and product integration into drug/device combination products.
- Enable the progression of BioCryst’s biologics portfolio that currently includes protein-based modalities as liquid 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 matter expertise for technical due diligence and for the technical as well as strategic content of the relevant drug product sections of regulatory submissions.
- Author and review high‑quality development reports, technical summaries and other documentation to support product development.
- Mentor and develop colleagues 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 small‑molecule 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 experience in end-to-end biologics drug product development (encompassing formulation, process development, scale up, technology transfer and 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 expectations and 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 fast‑paced 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
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.