Lab Supervisor

PharmaLogic•Austin, TX

10d

About The Position

The PET Laboratory Supervisor assists the PET Facility Manager with day-to-day laboratory operations, ensuring the safe, efficient, and compliant production of radiopharmaceuticals. The supervisor helps oversee laboratory technicians and chemists, supports adherence to regulatory guidelines and quality standards, and helps maintain a productive laboratory environment. The role may also involve producing radiopharmaceuticals, subject to required qualifications and compliance with applicable processes and procedures.

Requirements

Strong communication skills.
Familiarity with a GMP manufacturing environment and working with FDA and FDA cGMP regulations.
Ability to multitask, manage time, and work in a team environment.
Ability to work varying shifts and schedules and be reachable at all hours.
Dependability and reliability.
Mechanical aptitude and manual dexterity for manipulating small items.
Ability to lift between 16 and 50 lbs and to frequently crawl, stoop, crouch, and kneel.
Ability to analyze situations, set priorities, and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment.
Effective organizational skills, commitment to continuous learning, and ability to work independently and as part of a team.

Nice To Haves

Bachelor’s degree in chemistry or a related technical science field preferred.
Two years of PET manufacturing experience or equivalent preferred.
Knowledge of molecular imaging techniques and pharmaceutical study design and execution desired.
Experience with laboratory procedures, radiochemistry techniques, analytical methods, HPLC, GC, TLC, radiometric measures, radiochemistry synthesis, US FDA cGMP, radiation safety principles, isotope production, and analytical equipment troubleshooting highly preferred.

Responsibilities

Supervise and assist with preparing PET isotopes and radiopharmaceuticals, including packaging and shipping radioisotopes.
Support the PET Facility Manager in meeting financial goals and operating within budget.
Assist in managing PET Production Technicians and PET Chemists.
Facilitate communication between site QA and production personnel.
Follow SOP guidelines for QC release testing of radiopharmaceutical products and raw, finished, and semi-finished materials; ensure compliance in managing environments and facilities.
Coordinate and assist with training site personnel.
Operate and maintain automated radiochemistry synthesis units.
Maintain experience with a broad range of isotopes and labeling methods.
Work with appropriate personnel to install, qualify, operate, maintain, calibrate, and troubleshoot onsite equipment.
Assist with improving current cGMP and non-GMP processes and identify compliance gaps.
Maintain a clean and safe work environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.
Schedule and communicate production schedules and personnel assignments.
Participate in generating and implementing personnel development plans.
Order and maintain materials and supplies as needed.
Participate with appropriate personnel in initiating and investigating investigation reports.
Perform other job-related duties as assigned by the PET Facility Manager.