Theranostics Manufacturing Associate

PHARMALOGIC HOLDINGS•New York, NY

About The Position

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.

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.
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.
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.

Nice To Haves

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.

Responsibilities

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.
A passion for continuous learning and curiosity to find innovative ways to improve our ways of working.
Perform other job-related duties as assigned.