Ratio is seeking a Scientist II, Process Development, CMC to join a growing team of scientists to provide scientific and technical expertise for radiopharmaceutical process chemistry and manufacturing development, supporting strategy and execution across multiple programs and CDMO partnerships. The ideal candidate will enjoy working in a collaborative, fast-paced, multidisciplinary environment.
Key Responsibilities:
- Contribute to the development, optimization, and scale-up of radiopharmaceutical production processes across multiple programs, advancing Ratio Therapeutics' lead and pipeline compounds from early development through external CMC.
- Lead scientific strategy and execution for novel radiochemistry experiments (e.g., Cu-64, Lu-177, Ac-225, Tb-161, Ga-68) to enable next-generation radiopharmaceuticals and drug-linker conjugates.
- lead Design of Experiments (DOE), process characterization, and robustness studies to define stability, scale up, critical process parameters, and control strategies.
- Author and approve protocols, technical reports, electronic lab notebooks, analytical methods, and CMC sections of regulatory submissions.
- Maintain audit-ready data integrity across experiments, method development, and process changes, ensuring alignment with CMC and quality procedures.
- Contribute to the automation and standardization of radiopharmaceutical process workflows, including programming, qualification, and troubleshooting of automated synthesis and dispensing systems.
- Mentor Associate Scientists; guide experimental design, troubleshooting, and data interpretation across project teams.
- Collaborate cross-functionally with Analytical Development, Quality, Regulatory, Radiation Safety, and Manufacturing to deliver CMC strategy and program milestones.
- Develop and apply radiation safety practices, SOPs, and handling standards for therapeutic and diagnostic radionuclides, contributing technical expertise to site-level safety initiatives.
- Participate in cross-functional and external forums, including technical reviews, and scientific conferences, representing CMC Process Development and contributing technical expertise.
Qualifications:
- PhD with 3-6 years of experience, MS with 8-12 years of experience, or BS with 10-14 years of experience in pharmaceutical or radiopharmaceutical process development, with deep direct expertise in radiochemistry, labeling chemistry, and CMC.
- Experience in contributing to complex radiopharmaceutical development programs, with proven ability to shape experimental strategy and scientific direction.
- Strong knowledge of radiopharmaceutical chemistry, including chelator/linker design (DOTA, NOTA, and next-generation chelators) and labeling with therapeutic and diagnostic radionuclides.
- Demonstrated experience in process development, scale-up, and technology transfer of radiolabeled drug products
- Hands-on expertise with HPLC, LC-MS, TLC, and other analytical techniques used to characterize radiolabeled drug products and intermediates.
- Proven ability to manage multiple experiments and workstreams in parallel, prioritize effectively, and deliver high-quality results to agreed timelines in a fast-paced environment.
- Strong technical communication skills - able to author and defend CMC documentation, technical reports, and method descriptions for internal and external partners, and regulators.
- Self-motivated and intellectually curious, with a collaborative approach and genuine interest in developing junior team members.
- Proficient with Microsoft Office and familiar with chromatography software, LIMS, and related laboratory informatics systems.
- Ability to lift 20-30 lbs as needed to perform laboratory and manufacturing activities.
The annual base salary for this role is expected to range between $130,000 and $160,000. 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.
