Scientific Laboratory Manager
This role requires a highly skilled and experienced professional to oversee the operation of an ebeam sterilisation dosimetry laboratory. The successful candidate will be responsible for maintaining the effectiveness of the site dosimetry monitoring program in accordance with GLP, GMP and regulatory requirements.
The key responsibilities of this position include:
1. Providing product and manufacturing support in a cGMP regulatory environment.
2. Supervising, developing, and mentoring employees within the team.
3. Developing and driving the site dosimetry program, updating as appropriate.
4. Managing and coordinating all the dosimetry lab activities, including coordination with providers and suppliers.
5. Ensuring that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
6. Writing documentation for dosimetry lab methods, equipment qualifications and equipment validation and providing guidance and feedback.
7. Supporting laboratory set-up and maintenance of laboratory equipment and consumables.
8. Driving the laboratory training program, knowing safety rules and regulations, and making sure all personnel are trained on safe work practices.
9. Reviewing laboratory results, to ensure accuracy of data and timely communication of results.
10. Ensuring the dosimetry lab is validated and controlled and comply with internal requirements, applicable regulations and ISO11137 standards.
11. Providing technical guidance and support, in the areas of dosimetric release methods, dose mapping procedures and dosimetry curve calibration.
12. Leading problem solving efforts related to dosimetric release and providing technical advice as required.
13. Supporting unplanned events and raising out of specification results in a timely manner.
14. Initiating and completing CAPAs and Change Controls in accordance with site procedures.
15. Analysing product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly. Generating and presenting quarterly and annual reports.
16. Liaising with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.