Summary: The Senior Director, Drug Substance, Technical Operations, plays a key leadership role responsible for antibody drug substance development and manufacturing throughout product lifecycle. This strategic position is responsible for leading technical operations for drug substance development and manufacturing. The Senior Director, Drug Substance is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer. This role provides the opportunity to build the drug substance organization and involves close coordination with various teams including drug product, analytical sciences, supply chain, clinical operations, regulatory, quality, and management.

Key Responsibilities:• Provide strategic and technical leadership for drug substance operations
• Lead all aspects of outsourced drug substance development and manufacturing activities
• Ensure compliance with FDA, cGMPs, ICH guidelines, and QBD principles 
• Build, develop and lead internal/external drug substance team, capabilities and network
• Partner with internal and outsourced project teams to achieve business goals
• Author, review and approve technical documents and regulatory filings

Ideal Candidate:• Bachelor’s degree or advanced degree in relevant scientific or engineering field.
• Minimum 15 years of relevant experience in biotech/pharma industry, with a focus on drug substance development and manufacturing for antibody products.
• Demonstrated track record of leading outsourced antibody drug substance operations.
• Experienced with CDMO management and outsourcing drug substance operations with demonstrated ability to effectively manage CDMOs globally
• Strong scientific expertise in development and commercialization of antibody co-formulation.
• Proven track record in successful drug submissions (IND, BLA, IMPD, MAA, etc.) and familiarity with phase-appropriate cGMP requirements.
• Exceptional problem-solving and decision-making skills, with the ability to integrate complex scientific information into drug development plans.
• Strong leadership skills with experience in managing and mentoring a high-performing team.
• Highly experienced with cGMPs, FDA, EU, ICH guidelines and CMC regulatory submissions
• Detail-oriented with a talent for anticipating and mitigating risks/issues.
• Excellent communication skills and the ability to work effectively in a fast-paced environment.
• Experience in a small company or start-up environment is preferred.

What We Offer• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Flexible PTO
• Two, one-week company-wide shutdowns each year.
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $255,000 to $270,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.