Director, MS&T Radiopharmaceutical Operations

Summary

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio 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 Rayze Bio https //

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…