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Senior/Executive Director, Global Supply Chain Operations

Nurix

San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Operations
  • Industry: Biotechnology
  • Post Date: 11/22/2022
  • Website: www.nurixtx.com
  • Company Address: 1700 Owens Street, Suite 205, San Francisco, CA, 94158

About Nurix

Nurix Therapeutics discovers drugs that harness the body's natural process to control protein levels.

Job Description

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.

Position

The candidate will build and lead a group responsible for supply chain operations-related activities across the portfolio to support manufacture of raw materials, regulatory starting materials (RSMs), active pharmaceutical ingredients (APIs), sourcing of excipients and components and production of drug product (DP), packaging and labelling of clinical trial materials and finished commercial DP. The ideal candidate will be a highly motivated leader with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

Principal Duties and Responsibilities

  • Overall responsibility for vendor management and business contact for all raw materials, RSMs, Drug Substance (DS) related activities, excipients and components, bulk and finished DP for clinical and commercial programs
  • 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)
  • Provide leadership teams projection of supply/demand and manage all inventories of raw materials, RSMs, DS, excipients and components, bulk and finished product to ensure no stock or interruption to clinical development (with clinical development team) or commercial distribution
  • Manage all global supply chains and logistics in support of demand for clinical studies and commercial products
  • Functionally responsible for all activities related to packaging and labeling and associated engineering
  • Management of distribution network/3PL for commercial product distribution across the globe
  • Coordinate characterization activities of late phase programs according to the principles of QbD (mapping studies, DOEs) to identify critical quality attributes and critical process parameters (including edge of failure and proven acceptable ranges) and implement DS Control Strategy to support NDAs/MAAs
  • Coordinate with CMC functions to develop and execute plans for the primary stability registration and validation batches of RSMs, DS and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations and to ensure adequate expiry and shelf-life
  • 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
  • Keep abreast of any changes in regulatory requirements that may impact supply chain efforts and distribution
  • Initiate and manage high-value intercontinental, cross-border, and domestic shipments
  • Support new products and product improvements by participating in cross functional core teams, including responsibility for infrastructure and documentation
  • Responsible as business lead for drug product serialization across the globe
  • Manage and Lead Supply Chain Projects & business continuity initiatives
  • 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
  • Own the planning process to ensure we are executing to the future sales forecast and communicate internally and to CMOs (raw materials, RSMs, API, excipients, components & Drug Product)
  • Implement and continuously optimize the Global SOP process

Skills and Background

  • BS with 20+ years of experience; degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline; advanced degree preferred
  • At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
  • Substantial experience leveraging US and International CRO/CMOs for the manufacture of raw materials, RSMs and cGMP DS and DP to meet aggressive timelines
  • Substantial experience with projects in clinical development (e.g., Phase 1 through Phase 3 including multiple pharmaceutical dosage forms such as tablets, capsules, topicals, etc.)
  • 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 are essential
  • Able to identify and resolve critical issues
  • Sufficient technical background and experience to work closely with other technical functional areas
  • Experience implementing technical, strategic, and operational plans
  • Proven understanding of global pharmaceutical distribution requirements
  • Proven ability to lead complex contractual negotiations with a deep understanding of financial considerations when it comes to procurement and supply chain
  • Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
  • Qualities of servant leadership and self-awareness required

 

Nurix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or genetics. In addition to federal law requirements, Nurix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Nurix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, or veteran status. Improper interference with the ability of Nurix’s employees to perform their job duties may result in discipline up to and including discharge.

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