Associate Director, Equipment Engineering

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:
Rayze Bio careers page.

The Associate Director, Equipment Engineering is an integral part of bringing Rayze Bio’s innovative drug products to patients in need. In this role, you will report directly to the Director, Engineering Innovation and be primarily responsible for leading a team of Engineers to achieve clinical and commercial manufacturing objectives at the Indianapolis site(s). The Associate Director, Equipment Engineering will manage a team of Engineers to successfully design, implement, maintain and improve process equipment with novel Radiopharmaceutical technologies including but not limited to custom Hot Cells, robotics, automation and digitization.

Additional responsibilities will include managing budgets and working with architectural and engineering firms and specialty equipment manufacturers to achieve our technology and commercialization goals.

• Accountable for continuous operation and maintenance of process equipment and automation systems for Radiopharmaceutical Clinical and Commercial manufacturing.
• Manage or support engineering capital and facility expansion projects specific to innovative isotope and drug product radiopharmaceutical manufacturing.
• Build and manage a team of highly talented engineers responsible for a wide range of engineering disciplines including automation, process and mechanical.
• Develop and maintain departmental procedures and processes related to equipment engineering activities.
• Support routine GMP manufacturing related activities including but not limited to, Deviation investigation, CAPA and change control.
• Design and implement engineering and related functional systems in alignment with BMS and Rayze Bio objectives.
• Work with Production, Quality, Digital IT, Validation and Facility Engineering counterparts to successfully develop and implement novel radiopharmaceutical technologies.
• Coordinate and manage external vendors, partners and service providers as required for the design and implementation of novel radiopharmaceutical isotope and drug product equipment technologies.
• Ensure Engineering personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.
• Review, author and/or revise technical documents (SOPs, URS’s, forms, reports, etc.) as needed.
• Ability to travel as required to support job role.

• 10+ years’ engineering experience on manufacturing equipment in a cGMP Biopharmaceutical or Radiopharmaceutical environment is strongly preferred.
• Proven engineering leadership and management experience.
• Demonstrated experience implementing automation and digitization projects.
• BS/MS Engineering degree.

• Strong GMP manufacturing equipment engineering experiences on at least one of the disciplines: automation, process, mechanical
• Deep understanding of GMP, validation, regulatory standards, and industry best practices.
• Strong track record managing budgets and engineering projects.
• Proven leadership and personnel management experience.
• Strong knowledge of injectable and/or radiopharmaceutical drug product manufacturing.
• Strong knowledge of Automation software platforms and GMP and data integrity controls in automation equipment.
• Commitment to continuous improvement and operational excellence.
• Excellent professional ethics, integrity, and ability to maintain confidential information.
• Organized and detail oriented.
• Strong time management and organizational skills.
• Strong interpersonal communication…