Division / Department: PharmaLogic

Position Title: Theranostics Manufacturing Associate

Reports To: Theranostics Laboratory Manager

Role Summary:

Join our team at the forefront of precision medicine. As a Theranostics Manufacturing Associate, you'll be part of a team bringing innovative radiopharmaceutical treatments from the lab to patients who need them most. You'll gain hands-on experience in producing and validating cutting-edge life-changing therapies. This hands-on position involves radiochemistry synthesis, aseptic processing, and quality control - ensuring every dose meets the highest standards of safety and innovation, in a collaborative, purpose-driven environment.

Job Responsibilities and Duties:

1. 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.

2. Operate and maintain automated radiochemistry synthesis units.

3. Operate and maintain onsite analytical equipment.

4. Assist with improvement of current cGMP and non-GMP processes.

5. Follow all SOP guidelines for manufacturing and QC release testing of radiopharmaceutical product, raw material, finished and semi-finished product, environment and facilities.

6. Maintain clean and safe work environment, performing radiation safety duties in compliance with safety and pharmaceutical regulations.

7. Maintain accurate production and test/validation results.

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

9. Perform other job-related duties as assigned.

Job Requirements / Skills / Education:
• 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.

Variable hours
40 hours/week