Head of Biologics Drug Product Development

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 180,000 - 240,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. in North Carolina seeks a Director of Drug Product Development to lead formulation and process development for parenteral biologics.

This role partners with CDMOs and internal teams to advance projects from discovery through transfer and commercialization, ensuring phase-appropriate execution and regulatory readiness. You will mentor teams, manage external partnerships, drive CMC strategies, and shepherd high-concentration protein formulations from preclinical to

Qualifications

• MS or PhD in a relevant field with 10+ years of end-to-end biologics drug product development experience.
• Experience directing and managing development with external partners.
• Strong regulatory, cGMP and biology/biophysics grounding.
• Proven ability to lead cross-functional teams in a fast-paced setting.
• Experience with high-concentration protein formulations and sterile dosage forms.

Responsibilities

• Provide leadership for formulation, process development and manufacturing of injectable biologics.
• Develop strategies through internal/external partnerships and product integration.
• Drive phase-appropriate development toward licensure and commercialization.
• Lead interactions with external partners and cross-functional teams.
• Mentor colleagues and manage regulatory documentation for submissions.

Skills

Leadership

External partnerships

Regulatory knowledge

Biochemistry/biophysics

Aseptic processing

Education

MS/PhD in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry

Job description

BioCryst Pharmaceuticals, Inc. in North Carolina seeks a Director of Drug Product Development to lead formulation and process development for parenteral biologics.

This role partners with CDMOs and internal teams to advance projects from discovery through transfer and commercialization, ensuring phase-appropriate execution and regulatory readiness. You will mentor teams, manage external partnerships, drive CMC strategies, and shepherd high-concentration protein formulations from preclinical to