Manager, Supply Chain

$150,000 - $150,000/Yr

Alumis - South San Francisco, CA

Full-time - Mid Level

Onsite - South San Francisco, CA

Professional, Scientific, and Technical Services

About the position

Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients suffering from autoimmune diseases. Despite the advancements in treatment over the last two decades, many patients with immunologic conditions still face significant challenges. Our mission is to fundamentally change the outcomes for these patients through innovative treatment solutions. As a Manager in the Supply Chain department, you will play a crucial role in managing clinical supply chain activities and serving as the Supply Chain Lead on Study Execution Teams for early-phase clinical studies. This position is pivotal in ensuring that our clinical trials are supported by a robust supply chain that meets the demands of our innovative therapies. In this role, you will support clinical supply chain activities for global Phase II and Phase III clinical studies. You will be responsible for developing a supply strategy and translating clinical study requirements into the demand and supply of Clinical Trial Material (CTM), ensuring a timely start to studies. Your oversight will extend to the packaging and labeling of CTM at Contract Manufacturing Organizations (CMOs), where you will collaborate with Quality Assurance to review and approve packaging and labeling batch records, label proofs, and packaging specifications. You will partner with cross-functional teams, including CMC, Clinical Operations, Quality Assurance, and Regulatory Affairs, to ensure the timely release and delivery of CTM to depots and clinical sites, all while adhering to global regulatory requirements. Monitoring CTM inventory at multiple depots and working closely with Clinical Operations will be essential to ensure sufficient inventory at clinical sites throughout the duration of studies. Additionally, you will support proposal and quote reviews, purchase requisitions, and invoice reconciliations and approvals. Your role will also involve generating and reviewing documents such as label text and temperature excursion records. Some travel may be required for this position.

Responsibilities

• Manage clinical supply chain activities and serve as Supply Chain Lead on Study Execution Teams for early-phase clinical studies.
• Support clinical supply chain activities for global Phase II/Phase III clinical studies.
• Support the development of a supply strategy and assist in translating clinical study requirements into demand and supply of Clinical Trial Material (CTM) to ensure a timely study start.
• Oversee packaging and labeling of CTM at CMOs, collaborate with Quality Assurance on review and approval of packaging and labeling batch records, label proofs, packaging specifications, and other related documentation.
• Partner with cross-functional teams (CMC, Clinical Operations, Quality Assurance, Regulatory Affairs, and others as required) to ensure timely release and delivery of CTM to depots and clinical sites in compliance with global regulatory requirements.
• Monitor CTM inventory at multiple depots and work closely with Clinical Operations to ensure sufficient inventory at clinical sites for the duration of studies.
• Collaborate with internal CMC team functions for CTM expiry update management of supply at clinical sites and depots.
• Support proposal/quote review, purchase requisitions, and invoice reconciliations/approvals.
• Generate and/or review documents such as label text and temperature excursion records.
• Some travel may be required.

Requirements

• Bachelor's Degree (Business, Logistics, or Supply Chain preferred) with 5 years of relevant work experience within the life sciences/pharmaceutical industry.
• Experience with clinical supply chain management including inventory management, packaging and labeling operations, and logistics.
• Familiar with Clinical Supply Chain systems (i.e., IRT) for inventory management for global clinical studies.
• Familiar with clinical blinding practices in global clinical studies.
• Strong working knowledge of the drug development process (Phase I-III) and CMC functions.
• Working knowledge of the FDA, cGMP, GCP standards, and regulatory guidance documents relevant to supply chain.
• Team player with strong communication and interpersonal skills for effective cross-functional collaboration.
• Highly organized and detail-oriented with strong analytical and problem-solving skills.
• Able to multi-task and handle multiple responsibilities and priorities simultaneously under constrained timelines.