Director, MS&T for Radiopharmaceutical Operations

Job description

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ Summary The Director of MS&T will provide strategic and technical leadership for commercial-stage manufacturing process ownership, technology transfer, process validation, and lifecycle management at the BMS Indianapolis Radiopharmaceutical Manufacturing Site. This role is accountable for all MS&T activities from the point of transition from Product Development — encompassing late-phase scale-up, commercial process technical leadership, technology transfer, process validation (Stages 1–3), and post-approval changes (SUPAC) — through the full commercial lifecycle of each product. This role serves as the primary technical SME and inspection readiness leader for GMP manufacturing at the Indianapolis site, driving rigorous technology transfer, process characterization, process validation, continued process verification (CPV), and sustained inspection readiness. The Director drives cross-functional collaboration across R&D/CMC, Quality, Operations, Regulatory Affairs, Supply Chain, and external CDMOs to ensure site capabilities support clinical and commercial program milestones, while maintaining ownership of the site's manufacturing science strategy, CMC regulatory support, process validation lifecycle, deviation and CAPA leadership, and sustained inspection readiness. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Own and lead all technology transfer activities post R&D/CMC to Indianapolis, Indianapolis-to-CDMO, CDMO-to-Indianapolis, and reverse transfers as the single accountable leader for planning, execution, documentation, risk management, and completion; govern comprehensive transfer plans defining scope, timelines, milestones, success criteria, and risk mitigation for each transfer event Lead late Phase 2/Phase 3 and commercial-scale transfers translating development-stage processes into robust, GMP-ready manufacturing processes; direct site-to-CDMO transfers packaging all process knowledge, batch records, and validation data for contract partners; own CDMO-to-Indianapolis reverse transfers ensuring full traceability, comparability, and operational readiness per ICH Q12; serve as the primary technical interface with CDMOs, managing relationships, reviewing deliverables, and ensuring alignment with BMS quality and regulatory standards Own and enforce VHP material compatibility review as a mandatory transfer gate, ensuring all materials, consumables, product contact surfaces, and equipment are confirmed VHP-compatible prior to GMP use. Conduct site readiness and gap assessments evaluating equipment capability, facility requirements and documentation gaps prior to each transfer; ensure analytical infrastructure alignment is confirmed in coordination with AS&T prior to each transfer event Lead MS&T throughout the manufacturing process development and continuous improvement for all commercial and late-phase clinical manufacturing processes at the Indianapolis site; ensuring that his organization maintain deep ownership of process understanding, process robustness, yield optimization, appearance/presentation standards, and technology performance across the product lifecycle; lead process characterization studies to establish design space, identify process sensitivities, and support regulatory filings — including characterization protocol authorship, execution, data analysis, and reporting Lead the MS&T organization throughout the process optimization activities during technology transfer and throughout the commercial lifecycle to improve yield, cycle time, robustness, and operator safety; manage optimization efforts within the change control framework and ensure regulatory impact assessments are completed appropriately; own SUPAC (Scale-Up and Post-Approval Changes) accountability — evaluate, plan, and execute manufacturing changes post-approval in compliance with FDA SUPAC guidance and ICH Q12, including regulatory reporting category assessments and CMC submission support Own the full Process Validation lifecycle across all three stages: (1) Stage 1 — Process Design/Knowledge Capture at Commercial Scale, leading knowledge-capturing activities to define commercial process design space, CPPs, and CQAs where supplementation at commercial scale is required, and ensuring full documentation of process design rationale transferred from Product Development into the MS&T technical package; (2) Stage 2 — Process Performance Qualification (PPQ), directing all PPQ activities at commercial scale including protocol authorship, execution oversight, statistical evaluation, and regulatory reporting per ICH Q8–Q12; and (3) Stage 3 — Continued Process Verification (CPV), owning the site CPV program including design and maintenance of statistical process control (SPC) frameworks, control charts, performance trending, and process capability assessments with timely investigation and response to performance signals Co-lead Annual Product Quality Reviews (APQRs) for Indianapolis-manufactured products; ensure manufacturing process data, CPV trending, deviation summaries, change control histories, and yield/quality performance are accurately compiled, statistically evaluated, and reviewed with Quality leadership; integrate APQR findings into process improvement prioritization and CPV program updates Serve as one of the technical SME leaders for the Indianapolis site during regulatory inspections (FDA, EMA, and others), representing MS&T process validation, technology transfer, CPV, and process lifecycle management; maintain inspection-ready documentation packages for all MS&T-owned activities; lead pre-inspection readiness assessments, mock inspection preparation for MS&T scope, and post-inspection CAPA management for MS&T-related observations Serve as the MS&T technical lead for post-launch activities including deviation investigations with process impact, change controls affecting manufacturing process, and technical complaint investigations requiring process-level assessment; lead root cause analysis and CAPA ownership for process-related events Lead and develop the Indianapolis MS&T team, directing commercial-scale process activities, process characterization, scale-up, process optimization, and CPV execution; own the site manufacturing science strategy and drive performance through active people management and individual development planning Develop and defend CMC sections and regulatory submissions for technology transfer, process characterization, process validation, and manufacturing changes supporting INDs, NDAs, and BLAs; author and approve all GMP documentation including transfer protocols, validation protocols and reports, SOPs, batch records, VHP assessments, change controls, and CPV reports Radiopharmaceutical-Specific Accountabilities Apply expertise in radiopharmaceutical manufacturing — radiochemistry, radiolabeling, and short half-life process execution — to ensure all transfers, process validations, and CPV programs are executed with appropriate speed, containment, and regulatory rigor; account for hot lab design, remote handling systems, and radiation shielding constraints in all MS&T planning. Partner with EHS and the Radiation Safety Officer to integrate radiation safety protoco