Manager/Senior Manager, Clinical Supply Chain

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

BeOne Medicines Ltd. seeks a Manager of Clinical Supply Chain to oversee planning, labeling, packing, and distribution for clinical programs. You will develop and manage supply plans to ensure continuous patient supply while reducing risk and waste, and collaborate with internal teams and external partners.

The role requires strong GMP/manufacturing systems experience, knowledge of IRT, and a track record of improving processes to scale the organization for the future.

Qualifications

• Bachelor's or master's degree in business administration, operations management, or a related field.
• Minimum of 5 years of progressive experience in supply chain, preferably within biotech/pharma/CRO.
• Strong knowledge of GMP, IRT, and regulatory requirements.
• Experience coordinating with CST, CMOs, and external vendors.

Responsibilities

• Represent the Clinical Supply Chain on CST and provide a high service level to internal stakeholders.
• Create supply and inventory plans and develop production schedules for clinical trial materials.
• Monitor schedule adherence and adjust production plans as needed.
• Manage GMP inventory, expiry management, and drug accountability.
• Oversee label & pack CMOs and distribution vendors with stakeholders.
• Investigate exceptions, implement CAPAs, and drive closure.
• Coordinate and track bulk shipments to CMOs, depots, and vendors.

Skills

Supply chain management

GMP knowledge

Stakeholder management

CAPA implementation

IRT systems

Education

Bachelor's or master's in business administration or operations management

Job description

General Description:

• The Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with management to develop and implement process improvements to build the organization for the future.

Essential Functions:

• 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.

• Oversee daily activities for FG label & pack CMOs and distribution vendors with internal stakeholders.

• 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

• Supports functional projects and process improvements related to drug supply. Assist in the creation or revision of process documents such as Standard Operating Procedures.

• Ensure staff who are in supportive roles for supply planning and business process development are meeting deliverables for successful study management.

Education/Experience Required:

• Bachelor's or master's degree in business administration, Operations Management, or a related field required.

• Minimum of 5 years of progressive experience in supply chain, preferably within the biotech, pharmaceutical, or CRO industry.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.