Research PET Radiochemist

Advocate Health•Winston-Salem, NC

2d•$29 - $43

About The Position

Develops and implements methods and manufactures PET radiopharmaceuticals in a GMP environment for preclinical and clinical PET imaging research. Performs and develops chemistry-based operations, including organic and analytical chemistry, and validates and verifies equipment and procedures. The Research PET Radiochemist executes radiopharmaceutical production in the GMP laboratory for preclinical and/or clinical research, following radiation safety protocols under the supervision of the PET Center Director. Training is provided for radiochemistry and quality-control operations. The role supports process development, analytical methods, standardized procedures, and cGMP documentation, while maintaining the GMP cleanroom environment and identifying process improvements. The Translational Imaging Program is a fee-for-service core unit supporting research imaging and PET radiotracer manufacturing. Its laboratory includes ISO 5 and ISO 7 classified cleanroom space, an external Quality Control Lab, a storehouse, a scanner, and process development laboratories. Access to classified areas requires appropriate gowning and aseptic techniques. The position often involves many hours per day in full cGMP gowning, including a facemask, hood, and double gloves, in areas of limited mobility while performing meticulous manual work requiring attention to detail.

Requirements

Bachelor's degree in Chemistry, Chemical Engineering, or a closely related field, with specific training or coursework in Organic or Inorganic Chemistry, or Pharmacology.
Experience in chemistry synthesis, with at least some academic training in basic chemistry and analytical separations of small molecules.
Strong oral and written communication skills.
Excellent recordkeeping and documentation skills.
Understanding of Microsoft Excel and Word, and ability to master other laboratory analytical computer software.
Outstanding interpersonal skills; high energy and motivation.
Follow radiation safety protocols and use appropriate gowning and aseptic techniques in classified cleanroom areas.

Nice To Haves

Academic training or experience in analytical methods, chemical synthesis, or Good Manufacturing Practices (GMP) methods.

Responsibilities

Execute radiopharmaceutical manufacturing for preclinical and/or clinical research in the GMP laboratory while following radiation safety protocols.
Support process development and develop methods for analyzing process intermediates and final products.
Develop, implement, and follow standardized operating procedures for production steps and parameters.
Write, revise, and execute batch records in accordance with cGMP documentation guidelines; follow SOPs for projects and processes entering the GMP facility.
Attend internal and external seminars, training sessions, and workshops to maintain competency in radiopharmaceutical production, regulations, and job requirements.
Operate laboratory and production equipment, including HPLC, GC, biosafety cabinets, incubators, chemistry hoods, and radiochemistry hot cells.
Assist with equipment and process validation, verification, and qualification; troubleshoot equipment and manufacturing processes.
Maintain the GMP cleanroom by performing scheduled cleaning of equipment and manufacturing areas as needed.
Write SOPs and maintain detailed laboratory notes and experimental batch records.
Identify opportunities for process improvement and support their implementation.