MS&T Associate Scientist/ Scientist
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.
Requirements
- 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
Nice To Haves
- 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
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
Benefits
- The annual base salary for this role is expected to range between $90,000 and $130,000.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
