Aseptic Process Engineer Jobs in Utah (NOW HIRING)

About Ratio Therapeutics

Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life. We are a team of passionate scientists, engineers, and business professionals dedicated to advancing the field of targeted radioligand therapy. To accomplish this, we utilize our proprietary TRILLIUM and MACROPA platforms: TRILLIUM allows fine-tuning of radioligand pharmacokinetics thereby enhancing the therapeutic index, while MACROPA simplifies the manufacturing process for the alpha-emitting isotope, actinium-225. These enabling platform technologies have resulted in an emergent pipeline of novel therapeutic candidates. We are looking for talented, dedicated, and creative individuals eager to help us advance these technologies from discovery research through clinical development. Join us in our quest to become the leading innovator in radioligand therapy and improve the lives of cancer patients and their families.

About the Position

Ratio is seeking an MS&T Associate Scientist/Scientist to support the buildout and phased expansion of our new radiopharmaceutical manufacturing facility in the Salt Lake City metropolitan area (West Valley City, Utah) and to support GMP manufacturing operations once the site is operational. The ideal candidate will enjoy working in a collaborative, fast-paced, multidisciplinary environment.

Initially, this role will focus on technology transfer and validation activities with emphasis on process validation and method validation. Over time, the MS&T Scientist will support ongoing technology transfers, lifecycle validation, periodic reviews of validated systems, change control impact assessments, and validation support for new projects and process introductions.

Key Responsibilities

• Author and execute technology transfer and validation documentation, including protocols, risk assessments, summary reports, and related lifecycle documentation
• Oversee process validation strategies including process qualification, continued process verification, and lifecycle management activities.
• Perform technology transfer and validation activities in alignment with project schedules and site procedures.
• Support optimization, characterization, and scale-up of radiopharmaceutical manufacturing processes.
• Create, review, and revise related documents, including SOPs, validation plans, master plans, and protocols.
• Lead and coordinate execution of validation and technology transfer activities
• Lead periodic review activities for validated systems
• Support change control through technology transfer, validation, and other required actions
• Partner cross-functionally with internal departments, and external vendors to ensure compliant execution of technology and validation activities
• Lead small to mid-sized projects and provide support for larger projects
• Support manufacturing process readiness and train personnel in aseptic principles, manufacturing processes, and other programs as required.
• Support regulatory inspections by the FDA, EMA, and other healthy authorities
• Participate in quality systems activities, including change controls, CAPAs, deviations, and investigations

Required Qualifications

• Bachelor's degree in Life Science, Engineering, or a related field
• 5+ years of relevant technology transfer or validation experience in a GMP-regulated environment
• 3+ years of experience with GMP aseptic manufacturing processes
• Hands-on experience with process validation and lifecycle validation practices
• Familiarity with risk-based validation principles and good documentation practices
• Ability to work safely in a manufacturing environment
• Strong organizational skills, attention to detail, and a practical, solution-oriented approach
• Strong communication skills with the ability to clearly summarize technical topics for cross-functional audiences
• Comfortable operating in a fast-paced environment with both strategic and hands-on responsibilities

Preferred Qualifications

• Experience with digital validation platforms such as ValKit or Kneat
• Experience supporting technology transfer and validation during facility startup or expansion
• Experience in radiopharmaceutical, pharmaceutical, biotech, or other highly regulated manufacturing operations
• Experience supporting change control, deviations, and validation impact assessments

The annual base salary for this role is expected to range between $90,000 and $130,000. This range is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The actual base salary offered will depend on a variety of factors, including qualifications, work experience, skills, level of education attained, certifications or other professional licenses held, the location in which the applicant lives and/or from which they will be performing the job, and other job-related factors permitted by law.