Sr. Process Engineer

Sr. Process Engineer

Indianapolis - RayzeBio - IN

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.

RayzeBio is seeking an experienced Senior Process Engineer to drive technical excellence and mentor team members in our rapidly expanding radiopharmaceutical operations. As our business continues to grow and scale, this role will be pivotal in leading initiatives that enhance hot cell and radioisotope production/purification processes, supporting both clinical and commercial expansion.

The successful candidate will provide engineering expertise to evaluate, select, and startup critical equipment in a new facility. This will include troubleshooting and problem solving across multiple areas as you work cross-functionally with Radiochemistry, Health Physics, and Production teams to evaluate, transfer, and scale cutting-edge radiopharmaceutical technologies, supporting the organization's strategic growth trajectory.

This position offers the unique opportunity to lead transformative projects that directly impact RayzeBio's continued growth and leadership in the industry.

As a technical leader, you will champion the integration of advanced solutions, oversee optimization efforts, and help build a robust infrastructure to support increased production capacity and business expansion.

Job Responsibilities

• Provide technical leadership and expertise across radiopharmaceutical production, process development, and facility operations, supporting strategic expansion and innovation.
• Guide the evaluation, selection, commissioning, and optimization of critical production and purification equipment within the new facility.
• Lead troubleshooting and problem resolution efforts, collaborating with multidisciplinary teams to deliver effective solutions in a dynamic manufacturing environment.
• Identify and drive process improvements and technology enhancements to increase operational efficiency, reliability, and safety.
• Oversee the development and approval of technical documentation to ensure compliance with regulatory standards and best practices.
• Analyze process data and trends to advise on opportunities for quality and throughput enhancements as RayzeBio scales its operations.
• Build and foster collaborative relationships with internal stakeholders and external partners to support business growth and transformation.
• Provide mentorship, training, and thought leadership to engineering, operations, and technical staff; promote a culture of continuous improvement and excellence.
• Support the implementation and integration of new technologies and automation solutions in alignment with business objectives.
• Maintain current knowledge of industry advancements, proactively recommending and implementing improvements to maintain RayzeBio's leadership position.
• Champion safety and regulatory compliance throughout all engineering activities.
• May require up to 15% travel for project support and provide guidance during off-hours for critical needs.
• Provide guidance and support during off-hours for critical equipment emergencies.

Education and Experience

· Bachelor's degree in Chemical Engineering, Nuclear Engineering, Mechanical Engineering, or related discipline (Master's or PhD preferred).

· 7+ years of experience in radiopharmaceuticals, pharmaceuticals, or regulated manufacturing environments.

· Hands-on experience with particle accelerator operation and maintenance a plus.

· Advanced knowledge of hot cell systems, radiation safety protocols, and radioisotope handling.

· Expertise in purification methods, analytical instrumentation, and material transfer in controlled environments.

· Comprehensive knowledge of OSHA/NRC regulations and thorough understanding of cGMP, GDP, and FDA requirements applicable to radiopharmaceutical processing.

· Proven ability to lead projects and teams within a radiation-controlled environment.

Skills and Qualification

• Recognized technical leader with excellent mentoring, interpersonal, and cross-functional collaboration skills.
• Demonstrated expertise in project management, process improvement, and change leadership.
• Advanced written and verbal communication skills, including technical writing, report preparation, and presentation abilities.
• Strong analytical skills with acute attention to detail and strategic problem-solving capabilities.
• Ability to interpret and validate complex technical drawings, schematics, and manuals.
• Champions a "can-do" attitude, fostering a culture of innovation, adaptability, and responsiveness within the team.

Physical Demands

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment

• The noise level in the work environment is usually moderate.