Director, Drug Product Development

Role: Lead formulation and process development for biologics drug products within BioCryst’s portfolio, supporting preclinical through commercialization stages. Responsibilities: provide technical leadership, develop strategies for injectable biologics (liquid, lyophilized forms), oversee external CDMO collaborations, drive phase-appropriate development, and support regulatory submissions. Collaborate cross-functionally with Clinical Operations, Quality, and Device Development. Lead technology transfer, scale-up, validation, and manufacturing support; manage timelines, budgets, and risk. Qualifications: MS or PhD in Bio/Chemical Engineering, Pharmaceutical Sciences, or related field with ≥10 years’ biologics development experience, including formulation, process development, scale-up, and external partner management. Expertise in high-concentration protein formulations, aseptic processes, vial/pre-filled syringe/cartridge formats, regulatory cGMP standards, and biophysical principles. Proven track record supporting regulatory filings and working with analytical and quality teams. Strong communication skills and ability to operate in a fast-paced biotech environment. High-value biopharma specifics: biologics (proteins), liquid and lyophilized dosage forms, clinical-to-commercial development, multi-stakeholder collaboration, and external CDMO engagement. Work setup: not specified.