Research PET Radiochemist

Atrium Health Wake Forest Baptist; Winston-Salem (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Atrium Health Wake Forest Baptist's Translational Imaging Program seeks a dedicated professional to manufacture PET radiopharmaceuticals in a GMP environment for preclinical and clinical research, performing chemistry-based operations and validating equipment.

The role requires a Bachelor's in Chemistry or related field, with GMP training or coursework; candidates with analytical methods experience and strong documentation skills are preferred.

Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, or closely related field with GMP/analytical training.
• Academic training or experience in analytical methods, chemical synthesis, or GMP methods is preferred.
• GMP knowledge and experience with analytical separations are desirable.

Responsibilities

• Execute radiopharmaceutical manufacturing for preclinical and clinical research in the GMP lab facility under radiation safety protocols.
• Train to perform radiochemistry and QC operations following safety guidelines.
• Develop methods for analysis of process intermediates and final products.
• Write, revise and follow SOPs and batch records in accordance with cGMP.

Skills

Oral communication

Written communication

Chemistry synthesis

Recordkeeping

Excel

Laboratory software

Interpersonal skills

Education

Bachelor's degree in Chemistry, Chemical Engineering, or closely related field with GMP/analytical training

Tools

HPLC

GC

Job description

Job Description

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

Education/Experience

• 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.

Essential Functions

• Executes manufacturing of radiopharmaceutical productions for preclinical and/or clinical research in the GMP lab facility, following all the radiation safety protocols under the supervision of the PET Center Director.
• Training will be provided to perform the 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 including HPLC, GC, biosafety cabinets incubators and 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.
• Write SOPs and maintain detailed lab notes and batch records of all the experiments.
• Takes initiative to identify opportunities for process improvement and implementation.

Skills & Qualifications

• 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.

Work Environment

The Translational Imaging Program (TIP) is fee-for-service core unit that carries all the research imaging at the 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 the current good manufacturing practice regulations (cGMP) as well as the 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.

Physical Requirements

This position often requires many hours per day in full cGMP gowning with facemask, hood, and double gloves, within areas of limited mobility, while performing meticulous manual work requiring attention to detail.