Note: The job is a remote job and is open to candidates in USA. BeOne Medicines USA, Inc. is a rapidly growing company focused on fighting cancer. The Senior Manager of Clinical Supply Chain is responsible for managing drug supply activities for clinical studies, ensuring accurate supply to patients, and overseeing relationships with external supply partners.
Responsibilities
- Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC)
- Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines
- Create supply and inventory plans and develop production schedules for clinical trial materials
- Monitor schedule adherence of production schedules and make course corrections if needed
- Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability
- Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors
- Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure
- Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s)
- May coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs
- Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system
- Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses
- Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Lead cross functional projects and process improvements related to drug supply
- Creates and/or revise process documents such as Standard Operating Procedures
- Additional responsibilities as required
- Ensure staff who are in supportive roles for supply planning and business process development are meeting deliverables for successful study management
Skills
- Bachelor's or Master's degree in Business Administration, Operations Management, or a related field required
- Minimum of 7 years of progressive experience in supply chain, preferably within the biotech, pharmaceutical, or CRO industry
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan
- Commercial roles are eligible to participate in an incentive compensation plan
- All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards
- Voluntarily participate in the Employee Stock Purchase Plan
- The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
Company Overview
Company H1B Sponsorship