Radiopharmaceutical Manufacturing Facility Manager

Join a pioneering company dedicated to revolutionizing cancer detection and treatment in Hawaii. Our brand-new facility is equipped with cutting-edge technology, allowing us to make a meaningful impact in cancer diagnosis and patient care. As a small, dynamic team, we foster a collaborative, family-like environment where innovation thrives. Here, you’ll have the unique opportunity to influence strategy and help introduce groundbreaking new treatments to the state. If you’re passionate about advancing cancer care and want to be part of a team shaping the future of healthcare, we’d love to have you on board!

Role Summary:

The Facility Manager will play an essential role in leading PET (and SPECT) site operations in day-to-day manufacturing, quality control and distribution of PET and SPECT radiopharmaceuticals to satellite sites throughout the state of Hawai’i. In addition to managing operations, the position will hire, supervise and train staff in the production, QC and distribution of radiopharmaceuticals and provide site leadership to meet company goals, regulatory compliance and lead a customer-focused business.

Job Responsibilities and Duties:

• Hire, supervise and train PET (and SPECT) staff in the production / compounding, quality control testing and distribution of radiopharmaceuticals;

• Operate a facility that meets all applicable regulatory requirements, including Food and Drug Administration (FDA) cGMP manufacturing rules, Nuclear Regulatory Commission radiation safety, Department of Transportation rules governing shipping of radioactivity by ground and air, State of Hawaii Board of Pharmacy, and other applicable federal, state, and local island regulations;

• Manage and help coordinate manufacturing/compounding, quality control and distribution schedules to meet customer orders;

• Trained and qualified in all aspects of radiopharmaceutical operations noted above, and able to assist with production, quality control testing and distribution when required;

• Have a hands-on role in all quality assurance (QA) duties for the site, including:

-        materials acceptance and quarantine,

-        batch release & record review,

-        Radiopharmaceutical quality control, including sterility and environmental monitoring,

-        equipment maintenance/qualification/calibration/system suitability,

-        investigation (NCR/OOS) and corrective and preventative actions (CAPA),

-        SOP (Standard Operating Procedure) writing, maintenance and review,

-        regulatory filing (e.g. IND, (A)NDA, DMF) writing, maintenance and review,

-        inspection readiness,

-        data quality and integrity and other routine QA functions;

• Responsible for cleanliness of facility and maintenance of clean room in accordance with documented cleaning schedules;

- Assist RSO in running radiation safety program. Oversee radiation wipes and surveys on shipping containers, supplies, incoming packages, and workspaces are completed;

• Perform other job-related duties as assigned.

Job Requirements │ Skills │ Education:

• Requires a bachelor's degree in chemistry, radiology, nuclear medicine, nuclear physics, nuclear engineering or related field, or equivalent experience.

• Additional training (PhD, nuclear pharmacist etc.) desirable.

• Familiarity with a GMP manufacturing environment and working with board of pharmacy, NRC and FDA cGMP regulations required.

• Knowledge of radiopharmaceutical production and distribution desired.

• Experience managing multidisciplinary teams in a matrixed organization. Supervisory experience strongly preferred.

• Experience with cyclotrons, radionuclide generators, radiochemistry synthesis, US FDA cGMP, QC testing (e.g. HPLC, GC, TLC, sterility testing), Radiation Safety Principles, Isotopes production and analytical equipment troubleshooting and maintenance a plus.

• Superior teamwork, multi-tasking, and time/project management skills.

• Excellent communication, analytical, problem solving, presentation and computer/pc skills (including proficiency in Microsoft Suit and related software).

• Ability to work varying shifts.

Physical and Intellectual Requirements:

Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling; ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.

Come join our team and begin a fulfilling career with us by applying today.

Hawai’i Isotope Technology is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

Benefits Include:

retirement benefit program

Medical

Dental care

Disability insurance

Life insurance

Paid time off

Vision care