Üretim Teknisyeni (Teranostik)

Summary of Position

The Theranostic Production Technician is responsible for the manufacturing of radiopharmaceuticals, ensuring the accurate execution of synthesis processes in compliance with Good Manufacturing Practices (GMP), safety regulations, and company standards. As part of the production team, this role ensures that radiopharmaceuticals used in theranostic applications are produced efficiently, accurately, and in accordance with all quality and regulatory requirements.

Essential Functions

• Operate and maintain production equipment used in the synthesis of radiopharmaceuticals.
• Perform production processes of radioisotopes used in theranostic imaging and treatment in compliance with GMP and Standard Operating Procedures (SOPs).
• Ensure accurate and detailed documentation of production processes, including methods, logbooks, and deviations.
• Monitor and optimize production processes to improve efficiency.
• Ensure compliance with safety and regulatory requirements in the production area, with particular attention to radiation safety protocols.
• Collaborate with the team to troubleshoot production issues and improve process efficiency.
• Perform routine maintenance and calibration of equipment.
• Support validation and qualification activities of production equipment.
• Participate in continuous improvement initiatives within the production environment.
• Ensure that products meet specifications and are delivered on time for customer use.
• Train new team members on production processes and equipment.
• Maintain a clean and organized work environment in accordance with established cleaning procedures.

Requirements

• Associate degree in Chemistry, Radiochemistry, Molecular Biology, Biomedical Sciences, or a related field.
• Experience in radiopharmaceutical manufacturing, pharmaceutical production, or other regulated production environments.
• Knowledge of Good Manufacturing Practices (GMP) and other regulatory standards (e.g., FDA, ISO).
• Understanding of radiation safety protocols and proper handling of radioactive materials.
• Strong attention to detail and ability to follow technical procedures and protocols.
• Good written and verbal communication skills.
• Ability to work both independently and as part of a team.
• Ability to work in a physically demanding environment.
• Flexibility to work in shifts, including weekends and holidays.

• Experience with radiopharmaceuticals, particularly in theranostics or related fields.
• Knowledge of radiochemistry and molecular biology.
• Ability to troubleshoot technical issues related to production equipment.
• Familiarity with SAP, LIMS (Laboratory Information Management Systems), or similar software.

• Residence in Kocaeli (Gebze) or Istanbul (Asia side).

Work Environment:

• This position requires working in a cleanroom environment with strict adherence to GMP, safety protocols, and sterile procedures.
• Exposure to radioactive materials is expected; therefore, proper use of personal protective equipment (PPE) and compliance with radiation safety regulations are required.