GMP Manufacturing Technician I

Mariana Oncology • Watertown, MA

80d

About The Position

We are seeking an experienced Radiopharmaceutical Technician I to join Mariana's Technical Operations organization, advancing personalized medicine and radiopharmaceuticals to treat a variety of cancers. This person will be focused on clinical production and manufacturing within a controlled GMP environment.

Requirements

• Associate degree or bachelor's Degree with experience working in a cGMP manufacturing environment in the pharmaceutical or biotechnology industry. Working experience in leu of education will be accepted.
• Experience working in a cleanroom or manufacturing setting is strongly preferred.
• Demonstrated experience performing aseptic techniques at a qualified operator level preferred.
• Understanding of GMP and cGMP regulations and guidelines.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Understanding of the radiation safety regulations and guidelines is preferred.
• Comfortable handling radioactivity and following proper ALARA (As Low As Reasonably Achievable) technique.
• Willingness to think and operate independently.
• Team-oriented mindset with no job too big or too small.

Responsibilities

• Contribute to the production of the next generation of radiotherapeutics for Mariana's clinical trial programs.
• Provide 'on the floor' support during manufacturing operations.
• Prepare production suite for manufacturing activities including daily checks/equipment calibration, solution preparation, and other activities as required.
• Be able to successfully train on aseptic techniques for manufacturing processes.
• Support and participate in the process validation, tech transfers, equipment qualification and routine production of all radiopharmaceutical products.
• Ensure production consumables are adequately stocked. Ensure that gowning is adequately stocked.
• Work with supply chain and QA/QC to receive and release raw materials in accordance with established procedures.
• Monitor the production-related equipment used to ensure proper function and report any maintenance needs to plant engineering.
• Support in performing scheduled maintenance on production equipment to prevent unexpected failures and extend equipment life.
• Adhere to all applicable procedures, cGLP, cGMPs, cGDPs, SOPs, Radiation Safety, Mariana policies and QMS and any other quality or regulatory requirements.
• Support the routine maintenance of the manufacturing facility.
• Assisting in training new team members on equipment operation, troubleshooting procedures, and best practices.
• Comfortable handling and working with radioactive isotopes.
• Support manufacturing quality events including deviations, OOS, CAPA, and change controls.

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Associate degree
• Number of Employees: 1-10 employees