Research PET Radiochemist

About the role

The Translational Imaging Program (TIP) is a fee-for-service core unit that carries out research imaging at Advocate Wake Forest including PET/CT, MRI and CT scanning, and PET radiotracer manufacturing processes for both preclinical and clinical imaging research studies in compliance with current good manufacturing practice regulations (cGMP) and other applicable regulations. The TIP lab consists of ISO 5 and ISO 7 classified cleanroom space along with an external Quality Control Lab, store house, scanner and process development laboratories. Access to all classified areas requires appropriate gowning and aseptic techniques. Develops, implements methods, and performs manufacturing of PET radiopharmaceuticals in a GMP environment for preclinical and clinical PET imaging research. Performs and develops a variety of chemistry-based operations, including organic and analytical. Performs validation and verification of equipment and procedures.

Responsibilities

• Executes manufacturing of radiopharmaceutical productions for preclinical and/or clinical research in the GMP lab facility, following all radiation safety protocols under the supervision of the PET Center Director.
• Receives training to perform radiochemistry and QC operations following all safety protocols.
• Uses specialized education and training to support process development and develops methods for analysis of process intermediates and final products.
• Develops, implements and follows standardized operating procedures (SOPs) for all the different steps for performing various production parameters.
• Writes, revises and executes batch records following cGMP documentation guidelines and follows SOPs in support of projects/processes that move into the GMP facility.
• Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current radiopharmaceutical productions, regulations and job functional requirements.
• Operates a variety of equipment including analytical instruments (HPLC, GC), biosafety cabinets, incubators, chemistry hoods and radiochemistry hot cells.
• Assists in performing equipment and process validation, verification, qualification.
• Troubleshoots equipment and manufacturing processes actively.
• Maintains GMP cleanroom environment by performing scheduled cleaning of equipment and/or manufacturing areas as needed.
• Writes SOPs and maintains detailed lab notes and batch records of all experiments.
• Takes initiative to identify opportunities for process improvement and implementation.
• Works full cGMP gowning with facemask, hood, and double gloves for many hours per day, performing meticulous manual work requiring attention to detail.

Requirements

• Bachelor's degree in Chemistry, Chemical Engineering, or closely related field with specific training or coursework in Organic or Inorganic Chemistry, or Pharmacology.
• Academic training or experience in analytical methods, chemical synthesis, or Good Manufacturing Practices (GMP) methods is preferred.

Skills

• Strong oral and written communication skills.
• Experience in chemistry synthesis, with at least some academic training in basic chemistry and analytical separations of small molecules.
• Excellent recordkeeping and documentation skills.
• Understanding of Microsoft Excel, Word, and ability to master other laboratory analytical computer software.
• Outstanding interpersonal skills, high energy and motivated.