Sr Mgr / Assoc Director - External Manufacturing

Company Description Allotera Therapeutics, Inc., headquartered in St. Louis, Missouri, is a clinical-stage biotechnology company developing next-generation, allogeneic CAR-T cell therapies for cancer. Using a proprietary gene-editing platform, Allotera aims to overcome key limitations of first‑generation cell therapies and enable scalable, off‑the‑shelf treatments with competitive biologics‑like cost of goods. The company’s lead program, WU‑CART‑007, targets CD7 and has shown best‑in‑class efficacy in T‑ALL/T‑LBL. This program has the potential to become the first approved allogeneic CAR‑T therapy for T‑cell malignancies, offering a meaningful impact for people living with cancer. Team members join a science‑driven, collaborative environment focused on advancing transformative cell therapies to patients. Role Description The Sr Mgr / Assoc Director – External Manufacturing is a full‑time, remote role responsible for overseeing contract manufacturing organizations (CMOs) that support Allotera’s clinical and future commercial programs. This role manages day‑to‑day external manufacturing activities, including production planning, batch execution oversight, deviation and CAPA follow‑up, and coordination of technology transfers. The position partners closely with internal process development, quality, and supply chain teams to ensure reliable supply of clinical materials, adherence to timelines, and alignment with regulatory and quality expectations. Responsibilities include monitoring CMO performance, driving continuous improvement initiatives, supporting GMP readiness and inspections, and ensuring manufacturing documentation is complete and accurate. The role also contributes to long‑term manufacturing strategy, vendor selection, and risk mitigation plans to enable scalable, cost‑effective cell therapy production. Qualifications Candidates should possess strong skills in Production Planning and Manufacturing Operations to oversee daily external manufacturing activities and ensure on‑time delivery of clinical materials. Candidates should possess capabilities in Manufacturing Operations Management to manage CMO relationships, monitor performance metrics, and drive operational excellence across external sites. Candidates should possess deep knowledge of Good Manufacturing Practice (GMP) to support compliant manufacturing, documentation, investigations, and readiness for regulatory inspections. Candidates should possess experience in Supply Chain Management to coordinate demand and supply planning, material flow, and inventory control for clinical and commercial programs. Advanced degree or bachelor’s degree in engineering, life sciences, pharmacy, or a related field, with substantial experience in biologics or cell therapy manufacturing. Demonstrated experience managing CMOs or external manufacturing partners in a regulated environment, ideally within clinical‑stage or commercial pharmaceuticals/biotech. Strong understanding of tech transfer, process scale‑up, and validation principles for cell or gene therapies, including familiarity with regulatory guidelines (e.g., FDA, EMA). #J-18808-Ljbffr Allotera Therapeutics