VP, Drug Substance

Scorpion Therapeutics; United States; Remote; USD 320,000 - 520,000; Full time

Job summary

BioCryst is seeking a Vice President, Drug Substance to oversee enterprise strategy and execution for the company’s small-molecule and biologics portfolio. The role combines strategic leadership with hands-on oversight of development, scale-up, and commercialization processes.

The candidate will guide regulatory submissions, vendor governance, and cross-functional partnerships, while building a high-performing team and managing budgets.

Qualifications

• PhD required in chemistry, biochemistry, chemical/biochemical engineering, or related field.
• 15+ years in drug substance development and manufacturing with significant leadership.
• Deep expertise in biologics (cell line, upstream/downstream) and/or small molecules (API development, scale-up, validation).
• Proven experience with external vendor governance, regulatory interactions, and global cGMP standards.
• Strong strategic, operational, and communication skills.

Responsibilities

• Lead end-to-end process development, scale-up, manufacturing readiness, technology transfer, process validation, and commercialization.
• Shape organizational strategy, capabilities, and external partnerships.
• Manage regulatory submissions and compliance.
• Build and develop a high-performing team.
• Oversee budgets and resource planning.

Job description

Role

Vice President, Drug Substance overseeing enterprise strategy and execution for BioCryst's small-molecule and biologics portfolio.

Responsibilities

• lead end-to-end process development, scale-up, manufacturing readiness, technology transfer, process validation, and commercialization;


• shape organizational strategy, capabilities, and external partnerships;


• manage regulatory submissions and compliance;


• build and develop a high-performing team;


• oversee budgets and resource planning.

Requirements

• PhD in chemistry, biochemistry, chemical or biochemical engineering, or related field;


• 15+ years in drug substance development and manufacturing, with significant leadership;


• deep expertise in biologics (cell line, upstream/downstream processing) and/or small molecules (API development, process scale-up, validation);


• proven experience with external vendor governance, regulatory interactions, and global cGMP standards;


• strong strategic, operational, and communication skills.

High-Value

biologics and small-molecule modalities; from early development through late-stage validation and commercialization; global regulatory experience; remote with periodic Boston-based work; domestic and international travel.

Collaboration

partners with Analytical and Drug Product Development, Manufacturing, Regulatory, and external vendors.

Location

remote with periodic Boston-based work; domestic and international travel.