Senior Radiochemist will apply extensive knowledge of radiochemistry in the manufacturing of clinical-grade radiopharmaceuticals to ensure the quality of clinical and investigational radiopharmaceuticals as specified by the standards stated in the USP Chapter <823> and 21 CFR 210, 211, 212. The individual will be familiar with equipment installation, maintenance, repair and technical support projects in functional areas of the radiochemistry laboratory.
The senior radiochemist will develop new approaches in the synthesis and labeling of novel radiopharmaceuticals for clinical use, and work with a multidisciplinary team in developing Chemistry, Manufacturing, and Control for investigational drug applications (IND) and New Drug Applications/Abbreviated New Drug Application (NDA/ANDA) submitted to the FDA. The individual will collaborate actively and develop new investigations in these areas.
The candidate will also report to the Associate Director and Directors of the PET Center and the Technical Manager of the PET Center for helping to manage and further develop standard operating procedures for the investigational Positron Emission Tomography (PET) drugs such that the facilities, equipment, and inventory control meet the associated regulatory requirements.
Key responsibilities:
- Lead the development of new procedures for the translation of new and/or novel radiotracers for investigational clinical use.
- Develop manual or automated radiosynthesis protocols for manufacturing clinical-grade radiopharmaceuticals
- Develop quality control methods for new or novel radiopharmaceuticals
- Plan and perform production and quality control of radiopharmaceuticals according to current good manufacturing practices and aseptic technique
- Ensure that all manufacturing equipment are suitable and in working condition and all raw materials are qualified and within expiry before radiopharmaceutical production
- Ensure that radiopharmaceuticals used for clinical and research applications pass all associated QC tests prior to release.
- Participate in root cause analysis and initiate investigations following any out-of-specification or deviation from radiopharmaceutical manufacturing procedure
- Perform updates and changes to SOPs through change control (CC) and corrective and preventive actions (CAPA)
- Oversee design and performance of method validations, installation qualifications, and preventative maintenance on related chemistry equipment working with the radiochemistry team
- Follow university and medical center radiation and laboratory safety policies
- Aid preparation of Chemistry, Manufacturing, and Controls (CMC) section for investigation of new drug (IND), New Drug Applications (NDA/ANDA)
- Develop Standard Operating Procedures (SOP) for manufacturing of clinical radiopharmaceuticals
- Aid Qualification and Validation runs for developed procedures when needed
- Prepare responses for FDA Information Request (IR) related to the CMC section
Update CMC for changes in SOPs
- Follow and keep abreast with standards, regulations, and guidelines related to radiopharmaceutical manufacturing (21CFR 212 and USP <823>)
Columbia University is an Equal Opportunity Employer / Disability / Veteran
Pay Transparency Disclosure
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.
