Site Manager

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The SiteManager’s primary role is to ensure all radiotracer operations within the site areperforming to the standards set by PETNET. The purpose of the role is to takeoperational responsibility for all manufacturing activities of radiotracers, initiallyat the PETNET Mount Vernon site and thereafter at the PETNET Dunstable site. Therole will ensure contractual requirements are met and that there is a highdegree of compliance with Company policy and procedures, as well as current licensingregulations and health and safety legislation. The role will help drive theproject management of the new site and will effectively lead and manage a teamof 20-30 employees.

Your tasks andresponsibilities:

• Manage the Site Operations and the production of all radiotracers at thesite, initially at PETNET Mount Vernon and then at PETNET Dunstable, incompliance with all UK Licensing Regulations (compliance to Health and Safetyrequirements, MHRA and EA licenses).
• Implement and maintain processes to ensure all facility operations meetrequirements for schedule (on-time delivery) and budget to support daily demandof all radiotracers, including:
  • Inventory management:
    • Timely and accurate procurement of radiotracer and other drugs, supplies,and materials.
    • Monitor inventory of traditional products (as applicable) andradiotracers.
  • Radiotracer production (synthesis, QC/QA, dispensing, etc.):
    • Provide FDG, NaF, and Other Products as required by customers.
    • Establish a basic understanding of all equipment functions (cyclotron,synthesis units, QC, dispensing, etc.), system maintenance, and troubleshooting.
  • Logistics management:
    • Maintain Department for Transport regulations and delivery schedules.
  • Facilities and equipment upkeep:
    • Maintain instruments, equipment, and other devices in exemplary workingorder.

• A key responsibility of the role initially will be to help drive theproject management of the new Dunstable site, including :
  • Liaising with contractors and functional teams across SiemensHealthineers,
  • Contribute to the development and maintenance of validation programdocuments including SOPs and Site Validation Master Plans (SVMP),
  • Assist in developing and managing the program schedule for schedulingimplementation, qualification/ validation activities of both manufacturing(cyclotron, minicells, and hot cells with ISO5 certification) and laboratoryequipment (HPLC, GC, IR, IC, TLC, pH, incubators, refrigerators, freezers,Etc.) via defined calibration and IQ/OQ/PQ procedures,
  • Support the development and managing the list of required protocols andprocedures required for new site start-up of the manufacturing and laboratoryequipment,
  • Manage the materials, equipment and consumable lists needed for a newsite start-up,
  • Lend support to design and execute validation studies that are compliantwith established procedures and aligned with industry best practices,
  • Coordinate to Ensure equipment is in place and serves its intendedfunction, employees are trained in specifics to the operation and that thebuilding performs as required.
• Ensure consistent achievement of a high quality and reliable service,with full customer satisfaction performance targets and without excessivefinancial and other penalties.
• Ensure consistent achievement of operational and capital budget results.
• Contribute to PETNET/Siemens Healthineers strategy.
• Provide sales support for business development activities, as required.
• Engage in ongoing continuous professional development to achieve fullawareness and technical knowledge of all current legislation and scientificdevelopment associated with PET radiopharmaceuticals and their production.
• Ensure direct and indirect reports are fully trained for the tasks whichthey routinely perform and those they may be expected to perform.
• Ensure equipment and facilities are adequately maintained, monitoring forEOL equipment needs and planning for replacement and onboarding of newequipment to maintain a constant state of operational readiness.
• Conduct operations in such a manner as to prevent risks to health andsafety of employees and others who may be affected, and to operate in line withboth Siemens Healthineers and the Trust’s Policies for Health, Safety andWellbeing.
• Ensure that all sub-contractors provide a high-quality service to complywith the service level agreements contained within the contract thus minimisingrisk to Siemens Healthineers.
• Manage the team effectively ensuring high levels of employee engagement,retention, and performance.
• Communicate regularly and effectively with the team, both on anindividual and team basis.
• Ensure continuous dialogue, feedback and development discussions are aninherent part of day-to-day operations both with direct reports and theirrespective teams.
• Embed and effectively drive the Healthineers Forum ensuring regulardialogue with the team and the agreement / follow-up of actions with the team.

To find outmore about the specific business, have a look at https://www.siemens-healthineers.com/en-uk/molecular-imaging/petnet

Your qualifications andexperience:

• 5 years’ experience in an environment associated with the manufacture,testing, and dispensing of radiotracers.
• Relevant experience of Good Manufacturing Practice (GMP), typically 2years post qualification.
• Experience of working in Radiotracer production facility, Aseptic serviceor 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 protocolsfor production of radiotracers in a clean room environment.
• Strong Project management experience.
• Leadership/management experience of production employees, whilst workingin a senior role, including strong delegatory skills.
• Substantial business planning experience.
• Demonstrable working knowledge of MHRA guidelines.
• High levels of commitment to customer service.
• Strong written and verbal communication skills.
• Organisational skills to track and trend performance.
• Quality-minded focus/QMS experience.

Ourglobal team:

We are a team of 66,000 highly dedicated employees across morethan 70 countries passionately pushing the boundaries of what’s possible inhealthcare to help improve people’s lives around the world. As a leader in theindustry, we aspire to create better outcomes and experiences for patients nomatter where they live or what health issues they are facing. Our portfolio,spanning from in-vitro and in-vivo diagnostics to image-guided therapy andinnovative cancer care, is crucial for clinical decision-making and treatmentpathways.

Ourculture:

We are part of an incredible community of scientists, clinicians,developers, researchers, professionals, and skilled specialists pushing theboundaries of what’s possible, to improve people’s lives around the world. Weembrace a culture of inclusivity in which the power and potential of everyindividual can be unleashed. We spark ideas that lead to positive impact andcontinued success.

As an equal opportunity employer, we welcome applicationsfrom individuals with disabilities.