Scientist​/Sr. Scientist , CMC Radiochemistry; on-site in SSF

Overview

Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy!

At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are devoted to advancing novel treatment options that offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face.

We are building an exciting and fast-paced company passionate about discovering and developing tomorrow’s most innovative cancer therapies.

Abdera is seeking a Scientist/Sr. Scientist, CMC Radiochemistry to join our growing organization. The ideal candidate will develop radiolabeling processes and perform analytical testing for therapeutic and diagnostic radiopharmaceuticals. This role will report to the Associate Director of CMC Development Operations and will be on-site based at our South San Francisco laboratories operation.

Salary Range: 125k – 160k

• Conduct radiochemistry experiments leading to robust radiolabeling processes and clinical formulations that meet target product profiles for diagnostic and therapeutic applications.
• Design and conduct experiments, critically evaluate data, draw appropriate conclusions, and develop a follow-up plan of action.
• Collaborate with multidisciplinary teams to define development project goals and timelines.
• Execute quality control testing and develop product and in-process controls specifications for radiopharmaceutical drug products in conjunction with staff analytical scientists.
• Troubleshoot, identify unusual results and design experiments that establish root cause and/or enhance knowledge of the product being developed.
• Author, revise and review technical documents including SOPs, development reports, test methods, experimental and qualification protocols, batch records, specifications and regulatory documents. Provide project data and progress status updates to internal cross-functional project team.
• Help to technology transfer package for transfer of radiolabeling and analytical methods to third party CDMO partners and serve as a representative on a project team in the capacity of process chemist expert.
• Recommend and implement continuous improvements with respect to safe handling of radioactive substances in the laboratory environment according to the radiation safety manual requirements.
• Maintain a safe working environment in adhering to the radiation safety manual requirements and support ad-hoc tasks as set in the policies (e.g., conduct area radiation surveys, contamination control, radioactive waste management).
• Ensure compliance with Health and Safety, policies, procedures and regulations applicable to the work.
• Maintain routine operations of the laboratories, including inventory counts, consumables ordering processes, and first line equipment maintenance.
• Conduct work according to best practices and where appropriate, regulatory guidance, international pharmacopeias, ICH, established protocols and standard operating procedures.

• PhD/MSc in Radiochemistry, Chemistry, Analytical Chemistry, Nuclear Engineering or equivalent knowledge or experience.
• 5+ years’ experience with academic and/or industrial radiopharmaceutical process development, formulation development, production, or tech transfer.
• Experience in method and formulation development to support regulatory filings is preferred.
• Hands on experience in radiolabeling with radioisotopes (radiometals preferred) used for diagnostic and…