Theranostics Manufacturing Associate

Job Responsibilities and Duties

• Responsible for production of radiopharmaceuticals:
  • Synthesis of diagnostic and therapeutic radiopharmaceuticals.
  • Analytical testing using HPLC, GC, TLC and other techniques.
  • Aseptic processing and fill/finish operations.
  • Completion of associated cGMP documentation.
• Operate and maintain automated radiochemistry synthesis units.
• Operate and maintain onsite analytical equipment.
• Assist with improvement of current cGMP and non-GMP processes.
• Follow all SOP guidelines for manufacturing and QC release testing of radiopharmaceutical product, raw material, finished and semi-finished product, environment and facilities.
• Maintain clean and safe work environment, performing radiation safety duties in compliance with safety and pharmaceutical regulations.
• Maintain accurate production and test/validation results.

Skills

• A passion for continuous learning and curiosity to find innovative ways to improve our ways of working.

Job Requirements

• Requires a bachelor's degree in chemistry or related field.
• Two or more years of laboratory experience are preferred.
• Familiarity with a GMP manufacturing environment and working with FDA and FDA cGMP regulations required.
• Knowledge of molecular imaging techniques and pharmaceutical study design and execution desired.
• Experience with laboratory procedures and analytical equipment (HPLC, GC, TLC, ICP, Radiation measurement) strongly preferred.
• Experience with radiation protection techniques and laboratory safety strongly preferred.
• Superior teamwork, multi-tasking and time/project management skills.
• Excellent communication, analytical, problem solving, presentation and computer/pc skills (including proficiency in Microsoft Suit and related software).
• Superior attention to detail in a fast-paced and dynamic environment.
• Ability to work varying shifts both independently and as part of a team.

Physical and Intellectual Requirements

• Required are a mechanical aptitude; manual dexterity for manipulating small items;
• ability to lift between 16 to 50 lbs. and to handle frequent crawling, stooping, crouching and kneeling;
• ability to analyze situations, set priorities and meet deadlines.