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Celgene Corporation

Sr Mgr Supply Chain

Celgene Corporation - San Diego, CA

Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, \u200bquest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Manage the entire clinical supply chain for complex multinational clinical trials. Lead the design of clinical packaging kits and clinical labels, review drug demand projections and supply plans, lead development, review and acceptance testing of IxRS systems. Work closely with Clinical Operations, Manufacturing, Quality and Regulatory Affairs to develop clinical supply requirements and plans. Coordinate and lead supply chain activities with Clinical Research Organizations and other external vendors. Ensure activities are properly documented in compliance with Receptos\/Celgene SOPs and applicable regulations.\u00a0 Responsibilities and Duties: Create, review and update supply plans to meet the demands of multiple international clinical trials Partner with Clinical Operations to identify and fulfill clinical supply demand assumptions Partner with CMC\/manufacturing team to define appropriate drug product manufacturing schedule to meet clinical demand Coordinate packaging kit design and supply strategy best suited to each trial Coordinate clinical label text creation, translation, review and approval Coordinate the development, maintenance and updating of IxRS systems Perform \/ coordinate review of technical GMP packaging requests and executed batch records Manage international distribution and logistics for multiple clinical programs, including during regulatory approval periods Manage post study product returns, accountability, and destruction activities Identify long term packaging and labeling plans that introduce new process efficiencies without sacrificing timely supply of investigational product Continually review department records to ensure compliance with Receptos\/Celgene standards and SOPs, as well as applicable regulations Manage Clinical Supply Chain sections of study Trial Master Files at Sponsor-level (if applicable), and\/or provide oversight and QC of logistics-related CRO-level Trial Master Files Develop strong internal collaboration with stakeholders Contribute information and recommendations to strategic plans and budgets Prepare and deliver reports (written and oral) to project teams as needed Minimum Requirements: Bachelor\u2019s degree in business, life sciences, engineering or related discipline Minimum 5 years in life sciences industry related experience, with at least three years in Clinical Supply Management of blinded global trials Understanding of GMP \/ GCP, pharmaceutical industry procedures and regulations Strong understanding of clinical study design, execution, and impact of drug product supply Demonstrated experience in clinical supply chain management and forecasting drug supply needs, preferably in large international studies with multiple drug depots Strong collaboration skills required, to coordinate team activities including cross-functionally at Receptos\/Celgene and with CROs and supply chain vendors Experience with preparation for commercialization preparation, including audit readiness, preferred Excellent communication and influencing skills; strong collaboration skills Strong attention to detail Ability to work independently with little direction Ability to multi-task and manage complex projects Proficiency in Microsoft Excel, PowerPoint and Project software Travel - up to 20% #LI-POST Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

11 days 13 hours ago

Celgene Corporation

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Sr Mgr Supply Chain Celgene Corporation - San Diego, CA, United States

   

Location: San Diego, CA

Company Profile:
Celgene is a multinational biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. There are numerous clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocyte leukemia (CLL), non-Hodgkin's lymphoma (NHL), glioblastoma, and ovarian, pancreatic and prostate cancer.