Associate Manager, Clinical Supply Chain

BeiGene

1d•$91,000 - $126,000

About The Position

The Associate Manager of Clinical Supply Chain manages drug supply activities for clinical trials, including planning, label development, labeling and packaging, and distribution. The role develops and oversees supply plans to ensure accurate, continuous patient supply while reducing risk and minimizing waste. It represents Clinical Supply Chain to internal stakeholders, manages external supply-partner relationships, and applies working knowledge of clinical supply best practices, IRT systems, and cGMP environments. The Associate Manager also works with management to develop and implement process improvements and supports staff responsible for supply planning and business process development in meeting study-management deliverables.

Requirements

Bachelor's or master's degree in Business Administration, Operations Management, or similar education.
At least 4 years of progressive supply chain experience, preferably in the biotechnology, pharmaceutical, or CRO industry.
Working knowledge of clinical supply best practices and IRT systems.
Experience working in a cGMP environment.
Efficient use of Microsoft Word, Excel, and Outlook.

Responsibilities

Represent Clinical Supply Chain on Clinical Study Teams and provide service to internal stakeholders, including Clinical Operations, Regulatory, Quality, and CMC; may also support or represent the function on program development teams.
Work with Clinical Operations to understand clinical demand requirements and align supply plans and timelines with study teams.
Create supply and inventory plans and develop production schedules for clinical trial materials with minimal supervision.
Monitor production schedule adherence and make corrections when needed.
Manage GMP inventory throughout the supply chain, prepare inventory reports, manage upcoming expiries, and ensure drug accountability.
Monitor daily activities of finished-goods labeling and packaging contract manufacturing organizations and distribution vendors with internal stakeholders.
Investigate exceptions, determine root causes, implement CAPAs, and drive their closure with minimal guidance.
Ensure label text and proofs comply with applicable rules, regulations, product specifications, and clinical study protocols.
Support IRT user acceptance testing, develop IRT supply strategies and DNX parameters, and oversee ongoing supply activities in the system with minimal guidance.
Coordinate and track bulk shipments to contract manufacturing organizations, depots, and vendors; maintain and track import licenses.
Develop supply strategies that maximize efficiency and minimize waste, identify risks, and develop mitigation plans with minimal supervision.
Support functional projects and process improvements related to drug supply.
Assist in creating or revising process documents, including Standard Operating Procedures.
Ensure staff in supportive roles for supply planning and business process development meet deliverables for successful study management.
Perform additional responsibilities as required.