Summary:
The Senior Director, CMC Operations (Technical Operations) position is a key leadership role responsible for planning and execution of development, manufacturing, and supply chain activities. The Senior Director, CMC Operations 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 CMC Ops organization and involves close coordination with various teams including drug substance, drug product analytical sciences, supply chain, clinical operations, regulatory, quality, and management.
Key Responsibilities:
• Provide operational leadership for planning and execution of technical operations
• Provide cross-functional project team leadership in partnership with functional leads
• Manage operational development, manufacturing and supply chain activities at CDMOs
• Ensure compliance with FDA, cGMPs, ICH guidelines, and QBD principles
• 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 technical depth in drug development, manufacturing, and supply for antibody products.
• Minimum 5+ years of relevant experience in CMC project team leadership, CMC project management, and/or CMC operations management.
• Demonstrated track record of development and commercialization of antibody products.
• Experienced with CDMO management and outsourcing technical operations with demonstrated ability to effectively manage CDMOs globally.
• The ideal candidate has expertise leading cross-functional CMC teams in development and commercialization of antibody co-formulation, and/or combination products.
• 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.
• Unlimited 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 $ 250,000 to $280,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.