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PET Manufacturing Facility Director

2 months ago


Columbia, Missouri, United States PHARMALOGIC HOLDINGS Full time
Job Summary

**Job Title:** PET Manufacturing Facility Manager

**Job Type:** Full-time

**Industry:** Pharmaceutical

**Company:** PharmaLogic Holdings

Job Description

**Role Summary:**

The Facility Manager will play a crucial role in leading PET site operations in day-to-day manufacturing and distribution of PET radiopharmaceuticals. The position will oversee and train staff in the production and distribution of radiopharmaceuticals and provide site leadership to meet company goals and lead a customer-focused business.

**Key Responsibilities:**

  • Oversee and train PET staff in the production and distribution of radiopharmaceuticals.
  • Operate a PET facility that meets FDA (Food and Drug Administration) cGMP, BOP, NRC or agreement state radiation safety, and other applicable federal, state, and local regulations.
  • Have a hands-on role in all PET quality assurance duties for the site, including materials acceptance and quarantine, batch release & record review, PET drug quality control, sterility, environmental monitoring, equipment maintenance/qualification/calibration, investigation (NCR/OOS) and corrective and preventative actions (CAPA), SOP (Standard Operating Procedure) writing, maintenance and review, inspection readiness, data quality and integrity and other routine QA (QUALITY ASSURANCE) functions
  • Manage and help coordinate production schedules to meet customer orders.
  • Trained and qualified in all aspects of PET operations, and able to assist with PET production where required.
  • Trained and qualified in all aspects of BOP operations and maintains required licensing to dispense products per business needs.
  • Hire, train, develop and manage the performance of PET staff.
  • Oversee inventory management, facility maintenance, equipment maintenance, and calibration.
  • Act as Pharmacist in Charge to meet customer demands.
  • Perform other job-related duties as assigned.

**Requirements and Qualifications:**

  • Requires a bachelor's degree in chemistry, Radiology, Nuclear Medicine, Nuclear Physics, Nuclear Engineering or related field, or equivalent experience.
  • Authorized Nuclear Pharmacist preferred.
  • Familiarity with a GMP manufacturing environment and working with BOP, FDA and FDA cGMP regulations required. Knowledge of molecular imaging techniques and pharmaceutical study design and execution desired.
  • Experience managing teams in a matrixed organization. Supervisory experience preferred.
  • Experience with HPLC, radiochemistry synthesis, US FDA cGMP, 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.