Lab Supervisor

PHARMALOGIC HOLDINGS•Atlanta, GA

About The Position

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside. PharmaLogic offers you an exceptional opportunity to join our dynamic team as a PET Labratory Supervisor! If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you. As the PET Laboratory Supervisor, you will assist the PET Facility Manager in overseeing the day-to-day operations of the laboratory, ensuring safe, efficient, and compliant production of radiopharmaceuticals. They are responsible for helping oversee a team of laboratory technicians and/or chemists, ensuring that all processes adhere to strict regulatory guidelines and quality standards while providing the means necessary for a productive and successful laboratory environment. The role is responsible for production of radiopharmaceuticals where needed/applicable, requiring qualification and compliance with related processes and procedures.

Requirements

Bachelor’s degree in chemistry or related technical science field preferred.
Two years of PET manufacturing experience or equivalent preferred.
Strong communication skills are required.
Familiarity with a GMP manufacturing environment and working with FDA and FDA cGMP regulations required.
Ability to multi-task, manage time and work in a team environment.
Ability to work varying shifts/schedules and be reachable at all hours.
Dependability and reliability.
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 while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.

Nice To Haves

Knowledge of molecular imaging techniques and pharmaceutical study design and execution desired.
Experience with laboratory procedures, radiochemistry techniques, analytical methods, equipment (HPLC, GC, TLC, and radiometric measures), radiochemistry synthesis, US FDA cGMP, Radiation Safety Principles, Isotopes production and analytical equipment troubleshooting highly preferred.

Responsibilities

Supervise and assist in the preparation of P.E.T. isotopes and radiopharmaceuticals, including packaging and shipping of radioisotopes.
Support manager in meeting all financial goals and objectives by ensuring the facility operates within budget and manages costs.
Assist PET Facility Manager in managing team of PET Production Technicians and PET Chemists.
Facilitate a strong communication channel between site QA and production personnel.
Follow all SOP guidelines for QC release testing of radiopharmaceutical products, raw materials, finished and semi-finished products.
Ensures compliance in the management of environments and facilities.
Coordinate and assist in training of site personnel.
Operate and maintain automated radiochemistry synthesis units.
Maintain experience with broad range isotopes and labeling methods.
Work with appropriate personnel to install, qualify, operate, maintain, calibrate and troubleshoot onsite equipment.
Assist with improvement of current cGMP and non-GMP processes and identify gaps in compliance.
Maintain clean and safe work environment, performing radiation safety duties in compliance with safety and pharmaceutical regulations.
Schedule and communicate production schedules and personnel assignments.
Participate in the generation and implementation of personnel development plans.
Order and maintain materials/supplies as needed.
Participate with appropriate personnel in the initiation and investigation of Investigation reports
Perform other job-related duties as assigned by PET Facility Manager.