Best suited to experienced CMC professionals with strong vendor management and cross-functional leadership skills working in a biopharmaceutical clinical-stage environment.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Nurix via Greenhouse
Senior Director, Manufacturing Operations
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
About Nurix Therapeutics
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
Source: Nurix careers (Greenhouse)