Director, Manufacturing Operations - Nurix Therapeutics

Position

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

Principal Duties and Responsibilities

• Lead the effort to identify and select, and manage Contract Manufacturing Organizations (CMOs) for the development and cGMP manufacture of raw materials, RSMs, 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
• Coordinates the design and execution of cross-functional CMC project plans and budgeting for early clinical development to commercial readiness
• Maintains frequent communication with the 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 identifies CMC critical path, risks and impediments to successful development and drives 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 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, or editing and approval of cGMP batch records, CMC regulatory and Quality documents
• Coordinate the preparation of technical reports, publications, and oral presentations

Required Qualifications

• BS with 15+ years’ experience; degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
• At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
• Excellent project management skills and working 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
• Experienced 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, exceptional interpersonal and management skills to collaborate with others on assigned projects (including both internal teams and external collaborators)

Bonus Qualifications

• Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
• Experience with managing US and International CMOs for commercial programs

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

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Application Process

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.