Senior Scientist, Radiochemistry

See Yourself at Telix

The Sr. Scientist, Radiochemistry will be responsible for manufacturing clinical and preclinical radiopharmaceuticals. This role will be part of tech transfer team to bring new radiotracers on board for clinical research. This person will also be accountable for supporting team members/technicians to ensure operational as well as patient standards are consistently maintained, ensuring production of PET radiopharmaceuticals to clinical and preclinical researchers, pharmaceutical companies, and radiopharmaceutical development companies. The Sr. Scientist, Radiochemistry will also service the development and optimization of generic and novel PET radiopharmaceuticals in a current good manufacturing practice (cGMP) environment. They will also 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

• 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.

Education and Experience

• Bachelors degree and 8+ years of experience, Masters degree and 6+ years experience, or PhD and 5+ years experience in commercial cGMP radiopharmaceutical manufacturing required.
• Training as an Authorized User for radioactive materials preferred.
• Experience in radiopharmaceutical production, Quality Control, and laboratory operations.
• Knowledgeable in current GMP/GLP and other regulatory requirements.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skill
• Attention to Detail: Have a strong attention to detail and be able to pick up errors before they become issues whilst also maintaining a helicopter view and be able to prioritise