Radiopharmaceutical Production Technician I in Somerset

We are seeking a Radiopharmaceutical Production Technician I to produce radiopharmaceutical products in a just-in-time environment to support clinical and commercial demand. This night shift position is responsible for executing all tasks associated with preparation, manufacturing, assembling, and packaging of radiopharmaceutical products, adhering to cGMP Guidelines to meet production demands. This entry-level role focuses on hands-on production tasks, material handling, aseptic technique, documentation, and compliance with safety and quality procedures. This position is for night shift: 10 pm – 6 am, Sunday – Thursday.

Essential Functions

• The Radiopharmaceutical Production Technician I performs all tasks associated with manufacturing in an aseptic environment, including properly donning required cleanroom garments and personal protective equipment in accordance with established safety protocols.
• The role requires performing aseptic manipulations concurrent with environmental and personnel monitoring and maintaining accurate documentation in compliance with cGMP guidelines.
• Performs complex batch record calculations and maintains all documentation according to cGMP guidelines and participates in assigned qualification and validation activities, as necessary.
• The associate adheres to the ALCOA+ principles in every aspect of GMP documentation.
• Supports radiopharmaceutical production readiness by performing material kitting, preparing laboratory solutions per established procedures, and maintaining stocked, clean, and organized workstations.
• Performs line clearance and manually cleans classified manufacturing areas used for sterile radiopharmaceutical production, ensuring all spaces and equipment are prepared in compliance with aseptic standards and site SOPs.
• Receives radioactive material and prepares radioactive packages for distribution according to the regulations and established SOPs.
• Prepares radioactive calibration standards to support equipment setup and operation.
• Verifies the work of peers, ensuring accuracy and compliance with SOPs, cGMP standards, and safety procedures.
• Follows As Low As Reasonably Achievable (ALARA) principles and NRC guidelines when working with radioactive materials safely.
• Due to manufacturing time constraints and patient demand, overtime may be required to ensure process continuation or completion.

Qualifications

• A Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Pharmaceutical Sciences) is preferred, or a minimum of two or more years of relevant work experience in a pharmaceutical or cGMP manufacturing industry.
• Additional certifications in radiopharmaceuticals or GMP are a plus.
• Experience with MS Office Suite.
• Aseptic processing and technique experience is preferred.
• Ability to learn and understand radiopharmaceutical production.
• Actively participates in and contributes to advanced safety programs aimed at ensuring the utmost protection for all personnel.
• Capable of handling physically demanding tasks, including lifting loads up to 40 lbs.
• Must possess good hand-eye coordination; close attention to detail is required.
• Ability to properly don and wear required cleanroom garments and personal protective equipment (PPE) in compliance with safety and regulatory standards.
• Flexibility to work varied shifts, including overnight and weekends, exhibiting a commitment to meeting production demands and deadlines.
• Demonstrates ownership and accountability for the production process, assigned production area, and associated documentation.
• Must be able and agreeable to working night shift: 10 pm – 6 am; Sunday through Thursday.

Work Environment

• Must be willing to work in a facility working with hazards (including radioactive, corrosive, flammable, and toxic materials) and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Work is performed in ISO-class environments requiring adherence to gowning and contamination-control procedures in addition to personal protective equipment (PPE).
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require to meet production demands and deadlines.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties. Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.