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 protocols into all MS&T activities; coordinate with AS&T on time-sensitive QC release strategies - sterility, endotoxin, radiochemical purity, and radionuclidic identity - ensuring site manufacturing execution is aligned within isotope decay constraints and optimized for minimal operator exposure

Education and Experience

• BS or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Radiochemistry, or related field; PhD preferred; or 12+ years progressive MS&T experience with senior leadership accountability
• 10-15+ years in MS&T, process development, or technology transfer within pharmaceutical, biotech, or radiopharmaceutical industries; 5+ years in senior people management with demonstrated success building high-performing technical teams
• Demonstrated ownership of end-to-end technology transfers across site-to-CDMO, and reverse CDMO-to-site programs; demonstrated experience leading process validation lifecycle (Stages 1-3), CPV programs, and APQRs in a commercial GMP environment; experience in radiopharmaceutical or sterile/injectable manufacturing strongly preferred

Skills and Qualifications

• Proven ability to own the commercial manufacturing process lifecycle - scale-up, process characterization, process optimization, PPQ, CPV, SUPAC, and APQR - within complex, multi-directional internal and external GMP networks
• Deep expertise in statistical process control (SPC), process capability analysis, and data-driven manufacturing performance management; strong knowledge of GMP regulatory frameworks - FDA 21 CFR Parts 210/211, ICH Q8-Q12, Q10, FDA Process Validation Guidance (2011) - and radiopharmaceutical-specific guidance; expertise in process validation, PPQ, and CDMO relationship management including deliverable oversight and performance management
• Familiarity with radiopharmaceutical manufacturing environments including hot cells, automated synthesis modules, radiation safety, and rapid release testing strategies coordinated with AS&T
• Exceptional communication, project management, and organizational skills; ability to influence across all organizational levels; strong commitment to scientific mentorship, emotional intelligence, and team-centered leadership; excellent professional ethics and integrity
• Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, stand, walk, and communicate effectively, and must occasionally lift up to 30 pounds. This role requires periodic work in GMP, laboratory, and hot lab environments with potential exposure to radioactive materials and VHP environments, requiring appropriate PPE and compliance with all BMS EHS and radiation safety protocols.

Work Environment

This role is based full-time at the BMS Indianapolis Radiopharmaceutical Manufacturing Site across office, laboratory, GMP, and hot lab environments. Regular travel to CDMO sites, internal BMS sites, and regulatory meetings is required, with targeted periodic travel to the San Diego R&D site. Periodic international travel may be required.

#LI-Onsite

Compensation Overview:

Indianapolis - RayzeBio - IN: $190,989 - $231,434

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.