ratiotx
MS&T Associate Scientist/ Scientist
West Valley City, Utah
Sponsorship not specifiedDetected 20 days ago
GMPFDA RegulatoryResearchCommunicationOrganizational Skills
About the role
- About Ratio Therapeutics Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life.
- Join us in our quest to become the leading innovator in radioligand therapy and improve the lives of cancer patients and their families.
Responsibilities
- 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
- 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 regulatory inspections by the FDA, EMA, and other healthy authorities
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 communication skills with the ability to clearly summarize technical topics for cross-functional audiences
- The ideal candidate will enjoy working in a collaborative, fast-paced, multidisciplinary environment.
Nice to have
- 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
Compensation
- The annual base salary for this role is expected to range between $90,000 and $130,000.
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