Address
Form of work
SalaryWell Established Medical Technology Company and Largest, Global Supplier of Positron Emission Tomography (PET) Radiopharmaceuticals, is Seeking to Recruit an Operations Manager to Join the London Based Team. The Site Manager’s Primary Role is to Ensure All Site Radiotracer Operations are Performing to Established Company Standards
The Role will Ensure Contractual Requirements are Met with Total Compliance to Company Policies and Procedures and Current Licensing Regulations and Health and Safety Legislation
ROLE
- Manage Site Operations and Production of All Radiotracers, with Secondary Site Responsibility to Follow
- Ensure Compliance with All UK Licensing Regulations (Compliance to Health and Safety Requirements, MHRA and EA Licenses)
- Implement and Maintain Processes to Ensure All Facility Operations Meet Requirements for On-Time Delivery and Budget to Support Daily Demand of All Radiotracers
- Recruitment, Management and Development of Personnel
- Project Management for Establishment of Additional Sites
- Contribute to Development and Maintenance of Validation Program Documents, Including SOPs and Site Validation Master Plans (SVMP)
- Assist in Developing and Managing the Program Schedule for Scheduling Implementation, Qualification/Validation Activities of Manufacturing (Cyclotron, Minicells, and Hot Cells with ISO5 Certification) and Laboratory Equipment (HPLC, GC, IR, IC, TLC, pH, Incubators, Refrigerators, Freezers, etc) via Defined Calibration and IQ/OQ/PQ Procedures
REQUIRED
- 5 Years’ Experience in an Environment Associated with Manufacturing, Testing and Dispensing Radiotracers
- Relevant Experience of Good Manufacturing Practice (GMP), Typically 2 Years Post Qualification
- Experience of Working in Radiotracer Production Facility, Aseptic Service or Similar Environment
- Experience Supervising Technical Staff and Management of Resources
- Experience of Safe Handling of Radioactive and Other Hazardous Materials
- Experience in Drafting and Executing URS, FDS, DQ, FAT, SAT, IQ, OQ Protocols for Production of Radiotracers in a Clean Room Environment
- Strong Project Management Experience
- Demonstrable Leadership/Management Experience
- Substantial Business Planning Experience
- Working Knowledge of MHRA Guidelines
- Organisational Skills to Track and Trend Performance
- Quality-Minded Focus/QMS Experience
