Job Summary

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>.

Responsibilities

• Perform dailies and assist Radiation Safety Officer for radiation safety and EHS related tasks and ensures complete documentation; 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.

• 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.

• 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.

• Completing production and quality control documentation for the prepared radio pharmaceuticals to ensure they meet regulatory and our company’s standards. Adherence to site quality program.

• Participates in all aspects of technology transfer for new products and drug sponsor/client relationships including validation of methods, qualification.

• Responsible for reviewing and executing batch records for clients and drug sponsors.

• Follows preparation for Standard Operating Procedures of the lab by identifying hazards, monitoring exposures, following the clinical program; reviews and handles documentation management if necessary; assess and make recommendations to management to increase efficiency.

• Help to ensure regulatory filings include CMC’s DMF’s and IND’s; properly completes documentation to eliminate liability with incomplete documents.

• 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.

Qualifications

• Master of Science or PhD required.
• Three years related experience and/or training in commercial cGMP radiopharmaceutical manufacturing required.
• 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.