Theranostics Production Specialist

Summary of Position

We are looking for a Theranostics Production Specialist to join our growing team. This role will be responsible for ensuring the production processes meet regulatory standards, maintaining production schedules, and implementing improvements in production efficiency.

Essential Functions

• Production Management: Oversee and manage the production process for theranostics products, ensuring that all activities are carried out in compliance with GMP, ISO, and regulatory standards.
• Quality Assurance: Conduct routine inspections and audits to ensure products meet quality specifications. Document all production activities, deviations, and corrective actions.
• Equipment Maintenance: Ensure proper operation of production equipment, perform calibration, and troubleshooting equipment as needed.
• Process Optimization: Identify and implement improvements to increase efficiency, productivity, and safety in the production processes.
• Collaboration: Work closely with the quality control team, R&D department, and other stakeholders to ensure smooth production and timely delivery of products.
• Training: Provide training to junior staff and assist in their development in production and quality assurance practices.
• Documentation: Maintain accurate and detailed production logs, batch records, and reports for regulatory compliance.
• Regulatory Compliance: Ensure adherence to safety, regulatory, and compliance standards, including environmental, health, and safety protocols.
• Continuous Improvement: Actively participate in root cause analysis and lead projects aimed at improving production processes and addressing challenges.

Requirements

• Bachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Radiopharmaceutical Sciences, or related fields. A master’s degree is a plus.
• Minimum of 2-3 years of experience in radiopharmaceutical production or theranostics, with a strong understanding of GMP guidelines.
• Experience with radiochemical synthesis, radiolabeling, and related processes.
• Familiarity with laboratory equipment and production systems.
• Proficient in the use of process control software and manufacturing systems.
• Solid understanding of GMP, GLP, GRP, ICH, and regulatory requirements.
• Familiarity with quality control and assurance in radiopharmaceutical production.
• Strong problem-solving abilities, with attention to detail in handling complex technical and regulatory issues.
• Excellent communication and interpersonal skills, able to work effectively with a diverse team.
• Collaborative attitude and willingness to work in cross-functional teams.
• Ability to work in a cleanroom environment, including the use of protective gear.
• Experience in theranostics and radiopharmaceutical production for personalized medicine.
• Experience with SOPs, training programs, and regulatory inspections.
• Familiarity with software such as SAP, LIMS, or other production management systems.