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.
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