Director, Drug Product Development

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🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👔 Director

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Biotechnology • Pharmaceuticals

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• 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

• 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

• Health insurance • Retirement plans • Flexible work arrangements • Professional development opportunities