Radiopharmaceutical Production Operator II at AMER in Pennsylvania

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Performs routine radiochemical synthesis, purification, compounding, and quality control functions supporting PET biomarker production at a cyclotron facility, including set-up, operation, routine checks, and preventive maintenance of manufacturing equipment such as cyclotrons and automated chemistry modules. This non-exempt role performs and documents all quality control testing and plays a crucial part in ensuring that manufacturing and QC activities meet cGMP, radiation safety, and applicable State and Federal requirements.

This role is on-site 5 days a week at our Wilkes-Barre, PA location.

Key Accountabilities:

• Executes routine synthesis, dispensing and QC sampling steps independently and in sequence, while maintaining aseptic technique and contamination control discipline throughout.
• Ability to identify processes drifting from the defined window and escalates before proceeding
• Assist in process qualification and process improvement initiatives working with cross functions teams.
• Supports commissioning and equipment qualification activities.
• Executes quality control testing using analytical instrumentation (TLC, HPLC, GC); analyzes and interprets results against established specifications and documents outcomes in compliance with GxP requirements.
• Participates in inspections, maintenance, and troubleshooting to support manufacturing and testing processes and equipment.
• Implements approved SOP changes to production and quality control processes, helping drive continuous improvement.
• Performs daily, weekly, monthly, and quarterly PM checks of cyclotrons, chemistry modules, and QC equipment per SOPs.
• Oversees routine logistics functions, including preparing product for shipment, coordinating courier schedules, and documenting as necessary.
• Identifies opportunities for efficiency in the production process.
• Maintains a clean, clutter-free facility and a well-organized production area and workflow.
• Train and mentor Radiopharmaceutical Production Operator I
• Provides exemplary customer support.
• Other tasks as assigned by supervisor.

Education and Experience:

• Associates degree or certifications in Chemistry, Radiochemistry, Biochemistry, or a related field required.
• 2+years of experience in a laboratory setting, preferably in radiopharmaceuticals, or a related industry.
• Knowledge of radiochemical synthesis, purification, and safe handling of radioactive materials required.
• Experience with precision measurement equipment.
• Ability to read and interpret engineering drawings, specifications, and manufacturing work instructions
• Strong problem-solving skills and attention to detail.
• Ability to work in a team environment and communicate effectively with diverse groups.
• Familiarity with regulatory requirements such as GMP and radiation safety practices.
• Willingness to work with radioactive materials and follow strict safety protocols.
• Ability to lift up to 50 lbs.

Working Conditions:

• Work is performed in a cGMP radiopharmaceutical production facility containing a cyclotron, hot cells, automated chemistry modules, and quality control laboratory instrumentation.
• Routine handling of radioactive materials is required. The incumbent must qualify and remain in good standing as an authorized radiation worker under the site's radioactive materials license, complete all required radiation safety training, wear assigned dosimetry, and participate in radiation exposure monitoring programs.
• Personal protective equipment, including lab coats, gloves, safety eyewear, and shielding, is required in all production and QC areas. Gowning for classified cleanroom areas is required as applicable.
• Production schedules are driven by the short half-lives of PET radioisotopes. This role requires early morning, overnight, weekend, and holiday shifts, as well as on-call coverage and overtime as needed to meet patient dose delivery schedules. As a non-exempt role, all overtime must be approved in advance in accordance with company policy.
• Work involves exposure to chemical reagents, compressed gases, cryogenic materials, and high-voltage equipment, with controls applied through established SOPs and safety procedures.
• Physical demands include prolonged standing, repetitive manual manipulation of small components behind shielding, and lifting or moving materials and shielded containers with mechanical assistance where provided.
• Occasional travel between production sites may be required.

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.