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Manager / Sr. Manager, Clinical Supply Chain Operations
Company: Kezar Life Sciences
Location: South San Francisco, CA
Employment Type: Full Time
Date Posted: 09/16/2021
Expire Date: 11/16/2021
Job Categories: Biotechnology and Pharmaceutical
Job Description
Manager / Sr. Manager, Clinical Supply Chain Operations
Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Manager / Sr. Manager for the Clinical Supply Chain department. The Manager / Sr. Manager will report to the Director of Clinical Supply Chain and will be the Supply Chain Operations point of contact for the Clinical Operations team. This role will be responsible for the day-to-day activities related to managing supply of Investigational Product (IP) including packaging, labeling and distribution through all stages of clinical development. Additionally, this position will work with internal and partner stakeholders to ensure timely and uninterrupted supply of IP and comparator products for assigned clinical trials. The Manager / Sr. Manager will also be the go-to person for getting the right IP from the right suppliers to the right place at the right time. The ideal candidate is self-motivated, highly accountable, professional and dedicated to supporting a growing biotechnology company.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar’s first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is entering Phase 1 clinical trials in several oncology indications.

RESPONSIBILITIES
• Work cross functionally with Clinical Operations, CMC, Quality Assurance and Regulatory Affairs as the unblinded contact to ensure uninterrupted and compliant supply of IP for assigned clinical trials and
Investigator Initiated Trials
• Collaborate with Clinical Operations and CMC to ensure that project needs, priorities, and timing are understood, defined, and communicated to the Clinical Operations and CMC teams for Kezar development
projects and Investigator Initiated Trials
• Actively manage a supply/demand forecast while monitoring the projections vs patient enrollment vs inventory for each assigned trial
• Work closely with Clinical Operations, Regulatory Affairs and Quality Assurance to develop clinical supply packaging and labeling to support the protocol(s), regulatory requirements, blinding and randomization
requirements, and ease of handling by the sites/patients
• Ensure accurate demand signals and inventory levels are incorporated into the overall supply plan for manufacture of IP
• Manage Contract Manufacturing Organizations (CMOs) for the support of Clinical Supply Packaging/Distribution, including but not limited to:
o Drafting Request for Proposals (RFP)
o Negotiating trial contracts and budgets
o Developing and managing the planning, scheduling, and coordination of the packaging and labeling projects to ensure the availability and timely delivery of clinical supplies
o Initiating POs and review/track invoices for approval
o Tracking inventory and shipments and resolve temperature excursions
• Support Clinical Operations in development and ongoing maintenance of interactive response technology (IRT) and other systems used for the management of IP in clinical trials
• Assist Quality Assurance in management of retest and expiry date assignments and extensions
• Manage domestic and international logistics and temperature monitoring of raw materials, samples and finished products to support clinical trials
• Monitor supplier performance to assess ability to meet quality and delivery requirements
• Other duties as assigned

REQUIREMENTS
• Knowledge of USA (FDA) and international GxPs (particularly GMPs)
• Knowledge in supply chain, planning or materials management, packaging and labeling, logistics including import/export, inventory management, and electronic systems such as IWRS/IRT or ERP
• Strong organizational, analytical, and interpersonal skills
• Demonstrated ability to work in cross-functional teams with minimal supervision
• Ability to prioritize and manage deadlines in a fast paced, dynamic environment with multiple projects
Contact Information
Website: https://apply.workable.com/kezar/j/...
Company Description:
Founded in 2015 and based in South San Francisco, Kezar (pronounced “keys are”) Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders – with the hope of helping people overcome their disease and live a better life. We are pioneering first-in-class, small molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. We are translating our innovative research in protein degradation (via immunoproteasome inhibition) and protein secretion (via the Sec61 translocon) to have a significant clinical impact in the most difficult-to-treat diseases.
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