Associate Director Supply Chain

The Supply Chain (SC) organization is looking for a hands on SC leader to help build and scale our biotech supply chain function from early-phase development through commercial readiness and launch.

This role is ideal for someone who has built supply chain infrastructure in a growing biotech environment and can operate across clinical, GMP, commercial, logistics, ERP and quality system interfaces.

Key Responsibilities

• Develop and maintain end-to-end supply chain process to support clinical development, late-stage readiness and commercialization
• Lead ERP implementation and supply chain master data governance
• Establish international brokerage, import/export, customs and trade compliance process
• Oversee domestic and international shipments of GxP materials, including cold chain and temperature controlled logistics
• Manage logistics providers, 3PLs, brokers, freight forwarders, depots, CDMOs, and other external partners
• Support material planning, inventory management, lot traceability and supply continuity
• Own shipment related deviations, temperature excursions, logistics failures, CAPAs and effectiveness checks in partnership with QA
• Lead DSCSA, serialization, product traceability, and commercial distribution readiness activities
• Develop SOPs, Work Instructions, process maps, KPIs, vendor scorecards and inspection ready documentation
• Serve as the SC SME during regulatory inspections, audits, and inspection readiness activities
• Support commercial launch readiness, including distribution model development, 3PL readiness, returns and recall support

Qualifications

• Bachelor’s degree in Life Sciences, supply chain, life sciences, engineering, or related field; advanced degree preferred
• 10-12+ years of supply chain, logistics, planning, external manufacturing experience in biotech/pharma; CAR-T or biologics preferred
• 5+ years of people leadership or functional leadership, including building teams, processes, systems and external partner networks
• Experience building supply chain operations in a clinical stage or commercializing biotech company
• Strong knowledge of GMP/GDP (Good Distribution Practice) expectations, cold chain logistics, lot traceability and quality systems
• Experience with ERP implementation, master data, DSCSA, serialization, 3PLs, brokers and international shipments
• Strong cross functional leadership across QA, Regulatory, Clinical and Technical Operations
• Experience supporting regulatory inspections, PLI readiness, late stage development BLA readiness or commercial launch
• Excellent organizational and negotiation skills
• Willingness to travel approximately 20% for business tasks

Who we are …

Immix Biopharma is committed to harnessing the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting.

Our lead asset, NXC-201, is a differentiated BCMA-directed CAR-T therapy being developed for relapsed/refractory AL amyloidosis—an area of critical unmet need. We are advancing rapidly toward potential approval and launch, with the goal of bringing a transformative therapy to patients.

• We are guided by three core values: Intelligence, Integrity, and Initiative. We are building a team of thoughtful, driven individuals who are motivated by the opportunity to make a meaningful impact for patients and to help define the future of our company.

Immix Biopharma, Inc. (Immix Bio) (Nasdaq: IMMX) is the global leader in relapsed/refractory AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that is designed to filter out non-specific activation.

NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT), with a registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.