Nurix, Inc. is hiring: Director, Manufacturing Operations in San Francisco

PositionThe 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 ResponsibilitiesLead 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 productsWorking in conjunction with technical teams, provide vendor management support in all logistics and operations to ensure on-time delivery of materialsCoordinates the design and execution of cross-functional CMC project plans and budgeting for early clinical development to commercial readinessMaintains 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 budgetsProactively identifies CMC critical path, risks and impediments to successful development and drives the identification and development of solutions to mitigate these risksServe as primary clinical supply chain contact, working collaboratively with internal and external partnersManage clinical supply planning and forecasting for study protocols and develop packaging/labeling and global distribution strategiesMonitor 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 drugCoordinate the preparation and/or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions to ensure timely distribution of clinical trial materialsCoordinate the process validation programs to support commercializationInitiate and manage high-value intercontinental, cross-border, and domestic shipmentsCoordinate the preparation, review, or editing and approval of cGMP batch records, CMC regulatory and Quality documentsCoordinate the preparation of technical reports, publications, and oral presentationsRequired QualificationsBS with 15+ years' experience; degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific disciplineAt least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environmentExcellent project management skills and working cross-functionally to develop and execute project plansExperience managing US and International CRO/CMOs for the manufacture of raw materials, RSMs and cGMP DS and DP for programs in developmentExperience with clinical supply chain, including forecasting supply needsExperienced with cGMP manufacturing and IND, CTA, and NDA filings; thorough knowledge of relevant FDA and EMEA regulationsExperience in supply chain management, and experience establishing pharmaceutical supply chain systems and networksAble to identify and resolve critical issuesSufficient technical background and experience to work closely with other technical functional areasExcellent 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 disciplineExperience with managing US and International CMOs for commercial programsFit with Nurix Culture and ValuesStrong team orientation; highly collaborativeSolutions and results-oriented focusHands-on approach; resourceful and open to diverse points of viewNurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/). Application ProcessNurix 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.