Senior Scientist

See Yourself at Telix

Responsible for manufacturing clinical and preclinical radiopharmaceuticals. Be part of tech transfer team to bring new radiotracers on board for clinical research. Supporting team members/technicians to ensure operational as well as patient standards are consistently maintained; ensures production of PET radiopharmaceuticals to clinical and pre-clinical researchers, pharmaceutical companies, and radiopharmaceutical development companies. Services the development and optimization of generic and novel PET radiopharmaceuticals in a current good manufacturing practice (cGMP) environment. Write and effectively execute protocols in conformity with the requirements outlined in 21 CFR Part 212 and USP <823>.

*Candidates will need to be on-site in Sacramento, California.

Key Accountabilities

• Sets up and prepares the chemistry units for synthesis and production in a cGMP environment in a manner that sets high standards conducive to leading by example.
• Is the subject matter expert for radiochemistry tech transfer and manufacturing qualification of newly developed radiotracers that will be qualified for clinical trial production.
• Performs quality control activities including HPLC, TLC and GC completion of batch records and packaging of the radiopharmaceuticals for transport in accordance with all regulatory requirements.
• Participates and designs studies to assist in product development of global Telix radiopharmaceutical assets.
• Assist Radiation Safety Officer to ensures complete documentation and compliance of the program; ensures safety procedures are practiced consistently meeting radiation safety and EHS activity standards in the lab.
• Help to maintain operation of the lab and its instruments including the Quality Management program; provide regular maintenance and repair of instruments or equipment, if needed.
• Responsible for reviewing and executing batch records for clients and drug sponsors.
• Assist in the writing of the CMC portion of INDs to support future clinical trials
• Performs other tasks or research projects as assigned by the COO when needed.
• Ensures that contracted standards of service are consistently upheld; resolves issues timely and professionally.

Education and Experience

• Master of Science or PhD
• Three years related experience and/or training in commercial cGMP radiopharmaceutical manufacturing required.
• Experience with routine PET diagnostic tracers (¹¹C, ¹⁸F, ⁶⁸Ga) is required.
• Experience with radiometal chemistry processes (⁸⁹Zr, ¹⁷⁷Lu, ⁶⁴Cu, etc) is preferred.
• Training as an Authorized User for radioactive materials preferred.
• Experience in radiopharmaceutical production, QC, and laboratory operations.
• Knowledgeable in current GMP/GLP and other regulatory requirements.