About the Position
Ratio is seeking a Scientist/Senior Scientist to join our growing team of scientists. This role may be based either at our Boston research headquarters or our future Salt Lake City manufacturing site. In this role, the successful candidate will be responsible for development of GMP manufacturing processes and technology transfer to internal and external manufacturing sites. The ideal candidate has a track record of successful GMP technology development, enjoys working in a collaborative and fast-paced environment, and will seek to maintain trustworthy relationships with interdisciplinary teams at partner organizations.
Key Responsibilities
- Independently develop and optimize radiopharmaceutical production processes to support advancement of Ratio's lead compounds.
- Lead the transition of early-phase drug product candidate production methods to processes appropriate for GMP technology transfer.
- Design and execute phase-appropriate process development strategies, including process qualification/verification/validation suitable for tech transfer and regulatory submissions.
- Serve as a main point of contact for manufacturing process technology transfer to internal and external manufacturing sites. Occasional business travel may be required (approximately 10%, Contiguous US) to facilitate technology transfer and troubleshooting activities at CDMO and internal sites.
- Author, review, and approve process related documentation (such as Master Batch records, protocols, reports and relevant sections of IND/IMPD sections and other regulatory filings).
- Lead manufacturing process training for manufacturing personnel.
- Support OOS/OOT and deviation investigations, identify root cause(s) and implement corrective and preventive actions related to manufacturing operations.
- Ensure compliance with GMP, GLP, and data integrity requirements, contributing to inspection readiness and continuous improvement of processes and workflows.
Qualifications and Requirements
- PhD in a life sciences field with 4+ years of relevant industry and/or academic experience (8+ years for MSc, 10+ years for BSc).
- Prior experience working with radioactive materials is required.
- Demonstrated experience in the development of radiopharmaceutical production processes and radiopharmaceutical manufacturing.
- Detailed working knowledge of cGMP and regulatory guidelines with a strong interest in advancing knowledge in this area.
- Experience with project management (experience managing external CROs or CDMOs is an asset).
- Proven aptitude in technical and regulatory writing.
- Ability to work effectively in a cross functional team environment and to influence without direct line-authority.
- High attention to detail and a quality and data-integrity oriented mindset.
- Open-minded and self-motivating attitude.
- Computer skills (Microsoft Office suite, chromatography software/LIMS, etc.).
- Ready and able to work in a laboratory environment.
The annual base salary for this role is expected to range between $130,000 and $165,000. 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.
