Senior Director, Manufacturing Operations

About the role

Own the supply chain and CMC project engine behind Nurix's clinical programs and commercial readiness. In this multifaceted role, you will select and manage CMOs, keep clinical supply flowing to trial sites around the world, and drive cross-functional CMC plans from early development toward commercialization, in a small, entrepreneurial environment with broad responsibilities.

Position Description

The position is a multifaceted role supporting several areas within the Technical Operations group, including supply chain management, CMC project management, and clinical labeling and distribution. The ideal candidate will be highly motivated and self-directed, with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

The Opportunity

• Lead the effort to identify, select, and manage Contract Manufacturing Organizations (CMOs) for the development and cGMP manufacture of raw materials, RSMs, and DS in support of ongoing clinical programs and commercial products (with finance and commercial teams)
• Manage global supply chains and logistics in support of demand for clinical studies and commercial products
• Working in conjunction with technical teams, provide vendor management support in all logistics and operations to ensure on-time delivery of materials
• Coordinate the design and execution of cross-functional CMC project plans and budgeting for early clinical development through commercial readiness
• Maintain frequent communication with cross-functional CMC project team members and key internal stakeholders so that all parties are aware of current project status, issues, contingencies, milestones, and budgets
• Proactively identify the CMC critical path, risks, and impediments to successful development, and drive the identification and development of solutions to mitigate these risks
• Serve as primary clinical supply chain contact, working collaboratively with internal and external partners
• Manage clinical supply planning and forecasting for study protocols and develop packaging/labeling and global distribution strategies
• Monitor IXRS portal processes, including high and low enrolling site settings, drug acknowledgement, depot and site supply levels, and IMP status of released lots or expired drug
• Coordinate the preparation and/or review of CMC sections of INDs, CTAs, NDAs, MAAs, and other regulatory submissions to ensure timely distribution of clinical trial materials
• Coordinate the process validation programs to support commercialization
• Initiate and manage high-value intercontinental, cross-border, and domestic shipments
• Coordinate the preparation, review, editing, and approval of cGMP batch records and CMC regulatory and Quality documents
• Coordinate the preparation of technical reports, publications, and oral presentations

What You'll Bring

• BS with 15+ years' experience; degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or a related scientific discipline
• At least 10 years of relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
• Excellent project management skills and the ability to work cross-functionally to develop and execute project plans
• Experience managing US and international CRO/CMOs for the manufacture of raw materials, RSMs, and cGMP DS and DP for programs in development
• Experience with clinical supply chain, including forecasting supply needs
• Experience with cGMP manufacturing and IND, CTA, and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
• Experience in supply chain management, and experience establishing pharmaceutical supply chain systems and networks
• Able to identify and resolve critical issues
• Sufficient technical background and experience to work closely with other technical functional areas
• Excellent written and verbal communication skills, and exceptional interpersonal and management skills to collaborate with others on assigned projects (including both internal teams and external collaborators)
• Bonus: Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or a related scientific discipline
• Bonus: Experience managing US and international CMOs for commercial programs

Salary Range: $270,300 - $295,700

The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate's relevant experience, technical expertise, and how their background aligns with the role's requirements.

Location: Onsite - Brisbane, CA

Fit with Nurix Culture and Values

• Strong team orientation; highly collaborative
• Solutions and results-oriented focus
• Hands-on approach; resourceful and open to diverse points of view