Remote VP, Drug Substance Strategy & Manufacturing

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 300,000 - 420,000; Full time

Benefits offered by this job

Remote work option

Job summary

BioCryst Pharmaceuticals, Inc. seeks a senior Drug Substance leader to drive enterprise strategy for small-molecule and biologics drug substances.

You will oversee end-to-end development, scale-up, technology transfer, process validation readiness, and regulatory interactions while shaping the externalization model and resource plan. You will partner with Analytical Development, Drug Product Development, MS&T, Quality, Regulatory, and Global Manufacturing to ensure robust, compliant, and

Qualifications

• PhD in chemical engineering, biochemical engineering, biochemistry, chemistry or related field.
• 15+ years of progressive drug-substance development, scale-up, technology transfer, and manufacturing.
• Experience leading drug-substance programs from early development to commercial readiness.
• Knowledge of cGMP manufacturing, quality risk management, and regulatory expectations.
• Ability to translate complex issues into strategic, executable plans.

Responsibilities

• Lead drug-substance strategy across small molecules and biologics from early development to launch readiness.
• Oversee phase-appropriate process development, scale-up, and manufacturing readiness.
• Provide technical oversight for technology transfer and regulatory submissions.
• Manage external CDMOs, vendor governance, and long-term supply resilience.
• Build and mentor a high-performing Drug Substance organization.
• Represent Drug Substance in governance forums and with stakeholders.

Skills

Executive leadership

Strategic planning

Cross-functional collaboration

Communication skills

Financial stewardship

Decision making under uncertainty

Education

PhD in chemical/biochemical engineering or related

Job description

BioCryst Pharmaceuticals, Inc. seeks a senior Drug Substance leader to drive enterprise strategy for small-molecule and biologics drug substances.

You will oversee end-to-end development, scale-up, technology transfer, process validation readiness, and regulatory interactions while shaping the externalization model and resource plan. You will partner with Analytical Development, Drug Product Development, MS&T, Quality, Regulatory, and Global Manufacturing to ensure robust, compliant, and