| Principal Responsibilities |
- Conduct radiochemistry experiments leading to robust radiolabeling processesand clinical formulations that meet target product profiles for diagnostic and therapeutic applications.
- Design and conduct experiments, critically evaluate data, draw appropriateconclusions, and develop a follow-up plan of action.
- Collaborate with multidisciplinary teams to define development project goalsand 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 establishroot 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 (eg.:conduct area radiation surveys, contamination control, radioactive waste management).
- Ensures compliance with Health and Safety, policies, procedures andregulations applicable to the work.
- Maintain the routine operations of the laboratories, including (but not limited to), inventory counts, consumables ordering processes, first line equipmentmaintenance.
- Conduct work according to best practices and where appropriate, regulatory guidance, international pharmacopeias, ICH, established protocols and standard operating procedures.
|
| Qualifications, Education & Experience |
- PhD/MSc in Radiochemistry, Chemistry, Analytical Chemistry, NuclearEngineering or equivalent knowledge or experience
- 5+ years’ experience with academic and/or industrial radiopharmaceuticalprocess development, formulation development, production, or tech transfer.
- Experience in method and formulation development to support regulatory filingsis preferred.
- Hands on experience in radiolabeling with radioisotopes (radiometals preferred)used for diagnostic and therapeutic applications; experience with alpha emittersis a plus.
- Experience with radiotracer analytical techniques, including High Performance
- Liquid Chromatography (HPLC), Radioactive detectors, Thin Layer
- Chromatography (TLC), pH meter, Osmometer preferred.
- Hands-on experience with automated radio synthesizing units is preferred
|
| Skills and Abilities |
- Strong knowledge of the radioactive material handling regulations, includingCDPH, NRC, IAEI.
- Functional knowledge of radiopharmaceutical process/formulation chemistry, standard concepts of radiochemistry, best practices, regulatory requirements for development of radiopharmaceuticals in various jurisdictions.
- Ability to plan and execute complex scientific projects. Strong analytical andtrouble shooting skills.
- Ability to handle more than one project at a time, multitasking, effectivecommunicator and collaborative with different teams.
- Ability to lift and carry heavy weighing up to 50 lbs.
|