Senior Manager / Associate Director, Supply Chain
Kezar Life Sciences, United States
Job Description
Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Senior Manager or Associate Director, Supply Chain. This position is responsible for the day-to-day activities related to managing Investigational Product (IP) supply, including forecasting, packaging, labeling / distribution through all stages of clinical development, and working with internal and external stakeholders to ensure timely and uninterrupted global supply of IP for assigned clinical studies. The Associate Director position may manage direct reports and partner with other Kezar functional leaders in CMC, Regulatory Affairs, Clinical Operations, and Quality Assurance (QA) in support of the study project teams.
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 now being studied in a Phase 1 clinical trial in several oncology indications.
RESPONSIBILITIES
- Work cross-functionally with Clinical Operations, CMC, QA, and Regulatory Affairs to ensure uninterrupted and compliant supply of Investigational Product (IP) for assigned clinical studies and/or Investigator Initiated Trials
- Work with Clinical Operations and CMC to define supply strategies for clinical studies and production plans as needed
- Forecast clinical trial demand for IP and ensure end-to-end supply plan for manufacture of API and drug product are aligned
- Identify and manage contract manufacturing organizations (CMOs) for Clinical Supply Labeling/Packaging/Distribution (including but not limited to):
- Request for Proposals (RFP)
- Negotiate/manage contracts and budgets and review/approval of invoices
- Develop and manage the planning/scheduling of the packaging and labeling
- Develop/control labels and approve batch records and manufacturing activities along with QA
- Manage/oversee distribution of IP
- Work with QA to ensure CMOs are in compliance with all cGMP guidelines and SOP requirements
- Lead/support the vendor selection, qualification, contract negotiation, development, and ongoing maintenance of interactive response technology (IRT) and other systems used for the management of IP in clinical studies
- Exercise good business and technical judgment in selecting methods, techniques, and evaluation criteria for obtaining results
- Other Duties as assigned
The Associate Director position will additionally:
- Develop SOPs, work instructions, policies, forms, trackers, etc., as needed to support Supply Chain activities
- BA or BS in a relevant field, or equivalent experience
- Minimum of 5 years of experience as Sr. Manager/ 7 years of experience as Associate Director in investigational pharmaceutical product supply chain management or related field, in addition to other experience.
REQUIREMENTS
- Strong knowledge and demonstrated experience in clinical supply management: planning, labeling, packaging, and distribution
- Strong initiative and desire to work in a fast-paced, team-oriented, and dynamic environment
- Creativity and flexibility in problem-solving; work collaboratively as part of a team
- Working knowledge of cGMP/cGCP/cGLP/cGDP regulations
- Excellent oral and written communication skills
- Excellent organizational skills: ability to plan and execute multiple ongoing projects
- Proficiency in Microsoft Excel, Project, and Visio or equivalents desired.
Kezar Life Sciences is an Equal Opportunity Employer