Director, Drug Product Development
BioCryst Pharmaceuticals, Inc.
August 26, 2026
Remote friendly (North Carolina, United States)
United States
Operations
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. Responsible for phase-appropriate development while working with external Contract Development and Manufacturing Organizations (CDMOs), from early discovery support through late-stage technology transfer, scale-up, process validation, and commercialization. Cross-functional partnership with Clinical Operations, Quality, & Device Development.
Essential Duties & Responsibilities
- Provide scientific, technical and operational leadership for formulation, process development and manufacturing of patient-centered injectable drug products (pre-clinical to licensure), primarily via external partners.
- Develop drug product development strategies; support integration into drug/device combination products.
- Enable progression of protein-based modalities (liquid and lyophilized) in vial, prefilled syringe, and cartridge-based presentations.
- Drive phase-appropriate development: formulation, manufacturing process, and container/closure for clinical trials through commercialization.
- Lead interactions with external partners; maintain collaboration with internal leaders and stakeholders.
- Support budgets, timelines, progress tracking, and risk identification/mitigation.
- Provide subject matter expertise for technical due diligence and regulatory drug product sections.
- Author/review development reports, technical summaries, and other supporting documentation.
- Mentor colleagues across internal and matrix teams.
- Stay current on CMC and global regulatory strategies and best practices.
Experience & Qualifications
- MS/PhD (Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related) + 10+ years end-to-end biologics drug product development (formulation, process development, scale-up, technology transfer, manufacturing support), including significant experience managing external partners.
- Proficiency in formulation and drug product process development, manufacturing processes/equipment, and regulatory expectations.
- Must have experience with high-concentration protein formulation, aseptic processes, vial/prefilled syringe/cartridge presentations, and liquid/lyophilization.
- Knowledge of regulatory guidelines and cGMP requirements.
- Strong biochemistry/biophysics grounding.
- Experience supporting regulatory submissions; partner with Analytical, Quality, and Regulatory functions.
- Proven external partner management in a fast-paced biotech environment.
- Excellent written/verbal communication; experience authoring technical and regulatory documentation.
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. Responsible for phase-appropriate development while working with external Contract Development and Manufacturing Organizations (CDMOs), from early discovery support through late-stage technology transfer, scale-up, process validation, and commercialization. Cross-functional partnership with Clinical Operations, Quality, & Device Development.
Essential Duties & Responsibilities
- Provide scientific, technical and operational leadership for formulation, process development and manufacturing of patient-centered injectable drug products (pre-clinical to licensure), primarily via external partners.
- Develop drug product development strategies; support integration into drug/device combination products.
- Enable progression of protein-based modalities (liquid and lyophilized) in vial, prefilled syringe, and cartridge-based presentations.
- Drive phase-appropriate development: formulation, manufacturing process, and container/closure for clinical trials through commercialization.
- Lead interactions with external partners; maintain collaboration with internal leaders and stakeholders.
- Support budgets, timelines, progress tracking, and risk identification/mitigation.
- Provide subject matter expertise for technical due diligence and regulatory drug product sections.
- Author/review development reports, technical summaries, and other supporting documentation.
- Mentor colleagues across internal and matrix teams.
- Stay current on CMC and global regulatory strategies and best practices.
Experience & Qualifications
- MS/PhD (Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related) + 10+ years end-to-end biologics drug product development (formulation, process development, scale-up, technology transfer, manufacturing support), including significant experience managing external partners.
- Proficiency in formulation and drug product process development, manufacturing processes/equipment, and regulatory expectations.
- Must have experience with high-concentration protein formulation, aseptic processes, vial/prefilled syringe/cartridge presentations, and liquid/lyophilization.
- Knowledge of regulatory guidelines and cGMP requirements.
- Strong biochemistry/biophysics grounding.
- Experience supporting regulatory submissions; partner with Analytical, Quality, and Regulatory functions.
- Proven external partner management in a fast-paced biotech environment.
- Excellent written/verbal communication; experience authoring technical and regulatory documentation.