Supervisor, Radiopharmaceutical Production - Night Shift
Somerset, NJ
Full Time
Mid Level
We are expanding and ramping up! Perspective Therapeutics is seeking a qualified and experienced Supervisor for our Radiopharmaceutical Production team. You will lead the laboratory procedures and processes involved in manufacturing to commercialize investigational drug products. You will be responsible for leading radiochemical synthesis, radiopharmaceutical manufacturing operations, with knowledge of relevant regulations including U.S. FDA 21 CFR 58, laboratory safety, radiation safety, and GMP operations. You will train, mentor, develop, and oversee the production staff in their nightly duties, promoting a culture of continuous improvement in manufacturing procedures. You will collaborate with Quality, Facilities, Safety, and other departments to promote cross-functional teamwork and cooperation on action plans/project management.
You will possess strong leadership skills, technical experience in a radiopharmaceutical or pharmaceutical manufacturing environment, with a keen understanding of regulatory compliance in the production of radiopharmaceuticals. You will have proven supervisory experience (hiring, training, performance management, staff development) along with excellent production operations and extensive knowledge of quality control, ensuring the safe and efficient manufacturing of high-quality radiopharmaceutical products. This is a hands-on night shift role and as production sites and trials expand, there will be opportunities for growth. For more information, visit our website at: www.perspectivetherapeutics.com.
RESPONSIBILITIES:
Supervise Production Operations: Manage the daily operations of the radiopharmaceutical production line(s) during the night shift, ensuring all processes are performed according to standard operating procedures (SOPs), safety guidelines, and regulatory requirements. Maintain accurate record keeping in accordance with GMP. Ensure cross training, scheduling and coverage are obtained on multiple production lines. Initiate discipline if necessary.
Team Leadership & Development: Lead and mentor a team of production technicians, ensuring effective communication, teamwork, and a positive work environment. Provide training and support to team members on SOPs, GMP standards, and safety protocols. Provide opportunities for both professional and personal staff development, succession planning, etc.
Quality Control & Assurance: Ensure compliance with Good Manufacturing Practices (GMP), cGMP, and all regulatory requirements. Oversee the monitoring of product quality and ensure that all produced radiopharmaceuticals meet the required specifications before release.
Production Planning & Scheduling: Collaborate with the production planning team, Senior Production Manager and Site Leader to ensure that production schedules are adhered to, and that resources (materials, equipment, personnel) are appropriately allocated to meet production targets.
Troubleshooting & Problem-Solving: Address, resolve and document any production issues that arise during the night shift, including equipment malfunctions, production delays, or quality concerns. Escalate issues when necessary to ensure timely resolution.
Safety & Compliance: Ensure all safety protocols, particularly those related to radiation safety, hazardous materials, and equipment operation, are followed. Promote a culture of safety within the team and ensure all team members are trained and compliant with safety regulations.
Documentation & Reporting: Maintain accurate and up-to-date records of production activities, including batch records, production logs, quality control documentation, and any incidents or deviations. Report key metrics and production performance to upper management.
Continuous Improvement: Actively participate in initiatives to improve production efficiency, reduce waste, and increase output while maintaining the highest quality standards. Provide feedback to the management team on process improvements and operational efficiency.
QUALIFICATIONS/REQUIREMENTS:
Perspective Therapeutics is an Equal Opportunity Employer.
You will possess strong leadership skills, technical experience in a radiopharmaceutical or pharmaceutical manufacturing environment, with a keen understanding of regulatory compliance in the production of radiopharmaceuticals. You will have proven supervisory experience (hiring, training, performance management, staff development) along with excellent production operations and extensive knowledge of quality control, ensuring the safe and efficient manufacturing of high-quality radiopharmaceutical products. This is a hands-on night shift role and as production sites and trials expand, there will be opportunities for growth. For more information, visit our website at: www.perspectivetherapeutics.com.
RESPONSIBILITIES:
Supervise Production Operations: Manage the daily operations of the radiopharmaceutical production line(s) during the night shift, ensuring all processes are performed according to standard operating procedures (SOPs), safety guidelines, and regulatory requirements. Maintain accurate record keeping in accordance with GMP. Ensure cross training, scheduling and coverage are obtained on multiple production lines. Initiate discipline if necessary.
Team Leadership & Development: Lead and mentor a team of production technicians, ensuring effective communication, teamwork, and a positive work environment. Provide training and support to team members on SOPs, GMP standards, and safety protocols. Provide opportunities for both professional and personal staff development, succession planning, etc.
Quality Control & Assurance: Ensure compliance with Good Manufacturing Practices (GMP), cGMP, and all regulatory requirements. Oversee the monitoring of product quality and ensure that all produced radiopharmaceuticals meet the required specifications before release.
Production Planning & Scheduling: Collaborate with the production planning team, Senior Production Manager and Site Leader to ensure that production schedules are adhered to, and that resources (materials, equipment, personnel) are appropriately allocated to meet production targets.
Troubleshooting & Problem-Solving: Address, resolve and document any production issues that arise during the night shift, including equipment malfunctions, production delays, or quality concerns. Escalate issues when necessary to ensure timely resolution.
Safety & Compliance: Ensure all safety protocols, particularly those related to radiation safety, hazardous materials, and equipment operation, are followed. Promote a culture of safety within the team and ensure all team members are trained and compliant with safety regulations.
Documentation & Reporting: Maintain accurate and up-to-date records of production activities, including batch records, production logs, quality control documentation, and any incidents or deviations. Report key metrics and production performance to upper management.
Continuous Improvement: Actively participate in initiatives to improve production efficiency, reduce waste, and increase output while maintaining the highest quality standards. Provide feedback to the management team on process improvements and operational efficiency.
QUALIFICATIONS/REQUIREMENTS:
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Pharmaceutical Sciences) is highly preferred.
- Additional certifications in radiopharmaceuticals or GMP are a plus.
- 6+ years of experience in pharmaceutical or radiopharmaceutical manufacturing, with 4+ years of production supervision or management.
- Hands-on experience with radiopharmaceutical production, radiological safety, and GMP-compliant manufacturing processes is required.
- Familiarity with regulatory requirements such as FDA, DEA, and cGMP guidelines
- Strong leadership and team management skills, with a proven ability to motivate and guide production teams.
- Excellent problem-solving and troubleshooting abilities, particularly in high-stakes production environments.
- Proficient in the use of production software and documentation management systems.
- Strong understanding of safety standards, particularly radiation safety, and hazardous material handling.
- Excellent communication skills including the ability present data in a comprehensive format to sr. leadership and the ability to work cross-functionally with other departments (e.g., Quality Assurance, Maintenance, Planning).
- Positive attitude and collaborative spirit needed.
- Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Must be able to work outside of regular work hours, (currently 8pm – 6am but will change) including off shift, weekend, and holiday work as business needs require.
- 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.
- Must possess good hand-eye coordination; close attention to detail is required.
- Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
- Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
Perspective Therapeutics is an Equal Opportunity Employer.
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