About the job
At abcellera, we believe in the power of medicine to change lives. Our mission is to continually surpass expectations and deliver transformative therapies to patients in need. We are committed to pursuing scientific rigor and embracing the challenges that come with innovation.
We are looking for a dedicated Clinical Supply Chain Manager to lead the comprehensive management of Investigational Medicinal Products (IMP) and supporting supplies for our global clinical trials. In this critical role, you will ensure that the right products are available at the right time and in optimal condition for our clinical studies and patients. Your strong collaboration skills will be essential as you work closely with cross-functional teams, including Clinical Operations, CMC, Quality Assurance, and Regulatory Affairs, while also overseeing external partners such as CMOs, depots, and couriers to implement effective clinical supply strategies.
Key Responsibilities:
- Develop and maintain global supply plans for clinical trials, including demand forecasting across AbCellera’s projects.
- Oversee and maintain global inventory across all central depots and clinical sites to ensure a seamless supply chain, utilizing ERP/inventory systems for precise record-keeping.
- Manage packaging, labeling, and distribution activities in collaboration with CMO partners.
- Coordinate global shipments of clinical supplies in strict compliance with international trade regulations, import/export requirements, and customs documentation.
- Supervise and qualify temperature-controlled shipments (cold chain), partnering with Quality Assurance to address any temperature excursions.
- Work with teams and vendors to establish and lead User Acceptance Testing (UAT) for Interactive Response Technology (IRT/IXRS) systems that manage inventory, randomization, and drug assignment.
- Ensure all clinical supply activities comply with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and applicable global regulations.
- Act as the Clinical Supply Subject Matter Expert on clinical study teams, collaborating with CMC and Regulatory Affairs on label approvals and submission requirements.
- Oversee drug accountability, returns, and destruction processes, ensuring thorough documentation and assisting in the development and management of the clinical supply budget for assigned studies.