Job Summary
We are seeking a highly skilled Radiopharmacy Production Manager to oversee the manufacture, storage, and distribution of radiopharmaceutical products.
* Develop and implement production processes to ensure compliance with regulatory requirements and EU-GMP guidelines.
* Lead a team of radiochemists in the continuous production of PET tracers, focusing on early production and distribution times.
* Maintain accurate records of manufacturing activities and ensure adherence to EU-GMP Ch. 4.
* Manage the maintenance and qualification of rooms and equipment used in manufacturing, adhering to EU-GMP Ch. 3.
* Ensure the initial and periodic validation/re-validation of processes, following EU-GMP 5.21-5.24.
* Organize and conduct training for personnel, aligning with EU-GMP 2.8-2.12.
Key Responsibilities
We expect our ideal candidate to:
* Effectively manage an engaged and motivated team, leveraging internal resources and support.
* Contribute to developing and implementing standard operating procedures and training plans for the team.
* Recommend process improvements to enhance operational effectiveness.
* Assist in ensuring project delivery on time and within budget, as directed by senior management.
* Set clear objectives and provide comprehensive training to new staff members, ensuring they are equipped to perform all duties required on site.
Requirements
To be successful in this role, you will need:
* A recognized qualification/degree in natural sciences.
* At least one year of practical experience in nuclear medicine or radiopharmaceutical chemistry.
* A minimum of 5 years' industry experience in (radio)pharmaceutical production or manufacturing.
We offer a dynamic work environment and opportunities for growth and development. If you are passionate about leadership and committed to excellence, please apply today.