Associate Director of Validation

Bristol Myers Squibb • Indianapolis, IN

7d

About The Position

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/ RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Associate Director of Validation is responsible for leading the validation function to ensure that manufacturing facilities, utilities, equipment, processes, and computerized systems comply with regulatory and company standards for pharmaceutical/radiopharmaceutical production. This role oversees validation activities from initial planning through execution, manages a cross-functional team, and ensures alignment with regulatory requirements (cGMP, FDA, USP, and other relevant bodies). The ideal candidate has extensive experience in validation within radiopharmaceutical or pharmaceutical manufacturing and a strong technical background in process and facility qualification.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
• Minimum 8 years' experience in validation within pharmaceutical/radiopharmaceutical manufacturing, including large-scale capital project support (>$10M).
• Demonstrated understanding and hands-on experience with radiopharmaceutical or pharmaceutical validation systems and compliance.
• Direct experience managing validation or multidisciplinary project teams and external contractors.
• Strong knowledge of pharmaceutical validation practices, including cGMP and FDA/USP/OSHA regulatory requirements.
• Expert understanding of facility, utility, aseptic processing, and fill/finish equipment validation.
• Advanced proficiency in authoring and managing validation documentation (master plans, risk assessments, protocols, and reports).
• Familiarity with qualification of computerized systems and data integrity best practices.
• Solid background in vendor management, contract review, and cost controls within validation scopes.
• Excellent written, verbal, stakeholder, and team leadership communication skills.
• Proficient in MS Office Suite, validation software/applications, and computerized maintenance management systems (CMMS).
• Willingness to work in radioactive environments and follow strict safety requirements.
• Ability to travel and support validation at multiple domestic or international sites.

Nice To Haves

• Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent)

Responsibilities

• Lead, plan, and execute the validation strategy for manufacturing facilities, utilities, equipment, process technologies, and computerized systems.
• Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new or expanded manufacturing capabilities (facility, equipment, utilities, and processes).
• Direct and coordinate multidisciplinary validation teams, including hiring, mentoring, and professional development of validation personnel.
• Collaborate closely with site leadership, engineers, QA/Quality, and external vendors and contractors to ensure timely and compliant validation delivery for expansion, renovation, and site build projects.
• Ensure adherence to budget, schedule, and quality standards within validation scope across all site projects
• Review and approve technical documentation, validation protocols, risk assessments, and qualification deliverables.
• Manage and resolve deviations, CAPAs, and change controls related to validation and qualification activities.
• Support regulatory inspections, audits, and responses by ensuring site validation compliance and documentation integrity.
• Lead validation efforts to support site/facility strategic initiatives, new technology integration, and global harmonization as needed.
• Drive continuous improvement of validation processes for enhanced site reliability and regulatory compliance.
• Lead and mentor the deviation investigations team for the site.
• Uphold all safety standards; ensure safe handling of radioactive materials and hazardous equipment throughout validation activities.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level