Production Manager Hammersmith
Date: 5 Mar 2025
Location: United Kingdom
Company: curium
About Curium
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
To manage HRP production staff to aseptically prepare and supply radiopharmaceuticals and assist with maintenance of the Radiopharmacy Suites in accordance with principles of Good Manufacturing Practice.
Essential Functions
Radiation Protection
- Follow principles of ALARP
- Ensure all Radiation Protection principles are implemented and maintained at site level, staff are appropriately trained and adhered to at all times
Prepare Radiopharmaceuticals (PET: F-18 & Ga-68 products)
- Sanitisation/cleaning aseptic suite facilities.
- Manufacture of PET radiopharmaceuticals, Aseptic dispensing of PET radiopharmaceuticals using hotcells
- Ensure analysis of PET radiopharmaceuticals using relevant QC equipment and instruments
- Packing and dispatch of radiopharmaceuticals according to local guidelines and transport regulations
- Planning, collating received orders and populating production plans as required
- Adopting radiation protection technique at all times
- Effective management and communication with all colleagues to facilitate efficiency in both production and quality control related matters
- Participation in maintaining clean room
- Sanitation and transferring of consumables in the aseptic suite and hotcells
- Cleaning the hotcells and Radiopharmacy facility according to SOP’s
- Aseptic Suite monitoring including Environmental monitoring, Radiations monitoring
Quality and Compliance
- Recording of the checks and logs for production and QC equipment, include all other related logs
- Raising and completing deviation reports, OOS and MOOS where applicable
- Supervise and participate in Root Cause Analysis and CAPA for effective close out
- Effective management and communication with all colleagues to facilitate efficiency in quality related matters
- Ensure all GMP guidelines and processes are followed
- Participate in all validation, change control activities as necessary
Release product
- Releasing products according GMP guidelines, acting as Releasing officer under delegation of Quality Manager
- Approve of use and responsibility for unlicensed radioactive and non-radioactive medicinal products, undertaking risk assessments and evaluation to ensure they are of appropriate quality and fit for clinical use in patients
- Supervise and participate in the aseptic manufacture, dispensing, packaging and release of radiopharmaceuticals
- Provide specialist expertise in the radiolabelling and analytical methods that comply with radiation protection requirements
- Ensure continued and effective customer relations
Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues
Management and Training of staff
- Perform QC testing on all batches according to SmPC/procedure for batch release
- Review of batch documentation and Quality Control results before batch release
- Manage QC data spreadsheet and all QC equipment including their maintenance/calibration
Meeting company objective and targets both commercially and ensuring operating with budgets whilst maintaining compliance
Assisting with new Product Development
Requirements
Level of professional and intellectual ability
- Knowledge of radiation
- Shift work required
Education/experience
- Scientific Degree in Chemistry/Biology/Pharmacy
- 5-10 Years Experience
- Aseptic dispensing experience and Radiopharmacy experience or working with hotcell is desirable
- Experience in Quality Control of Radiopharmaceuticals
Addition job information
Knowledge
- working knowledge of pharmaceutical chemistry and good manufacturing practice is required
Skills
- Effective management skills
- Excellent team player
- Basic computer skills
- Good customer relation skills
- Communication skills
- Practical ability
- Excellent timekeeping competences
- Stress handling
- Excellent attention to detail
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.