GMP Specialist – Radiopharmaceutical Development

Job Description

GMP Specialist – Radiopharmaceutical Development As the GMP Specialist (Radiopharmaceutical Development) , you will perform and develop quality control and support production of clinical and research radiopharmaceuticals. You will provide scientific and technical expertise to support the growth of drug candidates, from radiolabelling experiments, automation, IND enabling studies, and GMP-compliant manufacturing.Who will you be working with? Our Client is a clinical stage radiopharmaceutical company developing treatments to significantly improve survival and quality of life for patients with cancer. As they continue to make advancements in their product development and clinical phases, there are opportunities to be part of this high-performing team who are experts in their field.What are the benefits? Brand new role Competitive salary package + relocation support (if required) Gain valuable experience working under a range of quality and regulatory frameworks as the products evolve to commercialization Culture of teamwork towards common goals What will you be doing? Provide expertise in GMP environment and execute GMP conform experiments / manage radiopharmaceutical manufacturing and dossier / protocols. Perform qualification work, validation and related documentation. Performing and developing Quality Control. Validate automated processes regarding to Radiochemistry / Pharmacy. Develop and review stability programs for radiopharmaceuticals. Development of procedures and formulations regarding stability and sterility of developed radiopharmaceuticals. Authoring and reviewing relevant documents such as reports and SOPs. Provide technical expertise, support, and adequate scientific interpretation and guidance to the team. Development and validation of a GMP compliant radiopharmaceutical production process. Maintain the generation of data and trending of production and quality parameters. Maintain the maintenance equipment, consumables and reagents for efficient functioning of radiopharmaceutical laboratories. Work with RSO to ensure compliance with the radiation safety program and site radioactive material license. Provide technical support to other teams or business units as required. Draft laboratory Standard Operating Procedures (SOP's), protocols, reports and other related GMP documentation as required. Note that this team performs some early morning starts and night shifts; however, this position will be required to work Monday to Friday 9am – 5pm for most of the time.What do you need? BS in Pharmacy, Science, or relevant field. Experience with radiopharmaceutical development is advantageous. Experience in automation of synthesises is advantageous. Experience in performance of qualification. Experience with method development for Trasis, iPhase is advantageous. Experience with method development for quality control is advantageous. Previous experience in assisting in CMC dossier for IND submission, desirable. Experience with alpha/beta/gamma emitting radionuclides preferred. Highly motivated and organized professional with the ability to work both with a team and independently. Ability to express technical topics clearly and concisely. Note that this role is working with radiation products in a safety controlled and regulated environment, so you must be comfortable working in this environment and maintaining a Queensland Radiation Use Licence (provided by the company).Apply now or, if you have any questions, please contact Christelle Capini at (emailprotected) . At Fuse, we specialise in recruitment for the scientific and manufacturing industry, and actively source a variety of roles for a broad range of organisations. If you are looking for a new opportunity, we’d love to hear from you! If you know someone looking for a job, refer them to us and we'll give you $500* if we find them a new role! How do your skills match this job? Sign in and update your profile to get insights. To help fast track investigation, please include here any other relevant details that prompted you to report this job ad as fraudulent / misleading / discriminatory. #J-18808-Ljbffr