Sr. Operator, Isotope Production

Job Responsibilities

• Execute routine isotope production (including material preparation, equipment setup, batch execution, post-batch material removal, waste disposal etc.) while ensuring compliance with GMP, site SOPs, NRC regulations, and management expectations.
• Perform radiochemical separations utilizing hot cell equipment and isotope purification within a glove box isolator in accordance with applicable batch records.
• Work with cross-functional teams, including Management, Quality, Radiochemistry, and Engineering, identifying opportunities to optimize production processes and enhance efficiency.
• Review completed batch records and production documentation for accuracy, completeness, and compliance prior to submission to Quality.
• Monitor and trend process performance data and contribute to ongoing process optimization efforts.
• Lead the review and revision of process SOPs, batch records, and other GMP documentation to ensure accuracy and continuous improvement.
• Support the investigation of quality events, including the implementation of corrective actions.
• Support inventory management, including consumables, spare parts, cleaning supplies and personal protective equipment (PPE).
• Promote and model a culture of safety and compliance with EHS and Radiation Safety programs.
• Use AI tools to enhance individual productivity and quality of work.

Education And Experience

• Associate’s degree, STEM field preferred.
• 6+ years’ experience operating in a GMP environment.
• Preferred: Bachelor’s degree in a STEM field.
• Previous experience operating within hot cells and/or glove boxes is strongly preferred.

Skills And Qualifications

• Fluency in English.
• Strong knowledge of GMP practice.
• Pipetting knowledge and experience.
• Knowledge of radiation safety principles.
• Knowledge of radiopharmaceutical manufacturing.
• Excellent professional ethics, integrity, and ability to maintain confidential information.
• Well organized and detail-oriented.
• Strong interpersonal communication skills.
• Motivated, adaptable, and able to work under pressure while meeting the needs of the production schedule.