Director, Drug Product Development

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and guide the formulation and process development for patient-focused parenteral drug products that support BioCryst’s biologics portfolio.

• Create strategies for drug product development through collaborations with internal and external partners.

• Lead product development initiatives in a manner suitable for each phase.

• Foster close collaboration with internal program leaders and stakeholders.

• Offer subject matter expertise for technical due diligence and regulatory submissions.

• Write and review high-quality development reports and technical documents.

• Mentor and nurture colleagues to build a high-performing team.

⛳️ Requirements

• MS / PhD in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related field.

• A minimum of 10 years of relevant experience in comprehensive biologics drug product development.

• Expertise in contemporary practices for formulation and drug product process development.

• Experience in high concentration protein formulation development, aseptic processes, and various presentation forms including vials, prefilled syringes, and cartridges.

• Familiarity with current regulatory guidelines and cGMP standards.

• Strong foundation in biochemistry and biophysics.

• Proven experience in supporting regulatory submissions.

• Demonstrated capability to manage external partnerships.

• Exceptional written and verbal communication skills.

🏝️ Benefits

• Health insurance

• Retirement plans

• Flexible work arrangements

• Professional development opportunities