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Director, Drug Product Development
BioCryst Pharmaceuticals, Inc.Director leading drug product development for BioCryst’s biologics portfolio. Overseeing formulation, process development, and collaboration with external partners.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in biologics drug product development, including formulation and process development, regulatory submissions, and collaboration with internal and external partners. Strong background in biochemistry and biophysics, with a focus on high concentration protein formulations and compliance with cGMP requirements.
Highest-signal resume keywords
Biologics Drug Product DevelopmentFormulation DevelopmentRegulatory SubmissionsCGMP ComplianceAseptic Processes
ATS Keywords
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Hard Skills
Formulation DevelopmentProcess DevelopmentHigh Concentration Protein FormulationAseptic ProcessesTechnical Due DiligenceRegulatory GuidelinesBiochemistryBiophysicsDrug Product Development StrategiesDevelopment Reports
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationMentoringCollaborationTeam Development
Certifications & Qualifications
MS / PhD in Bio/Chemical EngineeringPharmaceutical SciencesBiochemistry
Industry Keywords
Patient-Centered Drug ProductsBiologics PortfolioPhase-Appropriate DevelopmentExternal PartnershipsVial PresentationsPrefilled Syringe PresentationsCartridge Presentations
About the role
Key responsibilities & impact- Lead and direct formulation and process development for patient-centered parenteral drug products supporting BioCryst’s biologics portfolio
- Develop drug product development strategies through internal/external partnerships
- Drive product development efforts in a phase-appropriate manner
- Maintain close collaboration with internal program leaders and stakeholders
- Provide subject matter expertise for technical due diligence and regulatory submissions
- Author and review high-quality development reports and technical summaries
- Mentor and develop colleagues to contribute to a high-performing team
Requirements
What you’ll need- MS / PhD in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline
- At least 10 years of relevant field experience in end-to-end biologics drug product development
- Proficient in current approaches for formulation and drug product process development
- Experience with high concentration protein formulation development, aseptic processes, vial, prefilled syringe, cartridge presentations
- Knowledge of current regulatory guidelines and cGMP requirements
- Strong grounding in biochemistry / biophysics
- Demonstrated experience supporting regulatory submissions
- Proven ability to manage external partners
- Excellent written and verbal communication skills
Benefits
Comp & perks- Health insurance
- Retirement plans
- Flexible work arrangements
- Professional development opportunities