
Senior Scientific Supervisor
2 weeks ago
The company seeks an experienced Biological Laboratory Manager to oversee the daily operations of their cGMP-regulated laboratory.
- The manager will supervise a team of scientists and ensure they meet performance and growth objectives.
- They will lead the site's dosimetry program, reviewing and updating it regularly.
- The candidate will manage all dosimetry lab activities, including coordination with external providers and suppliers.
- They will author documentation for dosimetry methods, equipment qualification, and validation, and provide technical feedback.
- The manager will support laboratory setup and ongoing maintenance of laboratory equipment and supplies.
- They will oversee and enhance the laboratory training program, ensuring adherence to safety rules and training compliance.
- The candidate will review lab results for data accuracy and ensure timely communication of findings.
- The manager will maintain validation and control of the dosimetry lab in compliance with internal policies, regulations, and ISO11137 standards.
- They will offer technical expertise in dosimetric release methods, dose mapping, and dose calibration procedures.
- The manager will lead troubleshooting efforts related to dosimetric release and provide technical support as needed.
- The candidate will analyze product quality and process data using statistical tools to identify trends and drive improvements; prepare quarterly and annual reports.
- They will collaborate with cross-functional teams such as QA, Manufacturing, Engineering, R&D, Regulatory Affairs, and Purchasing to ensure timely task completion.
Requirements:
- A third-level Science or Manufacturing qualification is required.
- The candidate must have a minimum 4 years' work experience in a similar environment.
- Experience with electron beam or other sterilisation technologies is desirable.
- Knowledge of ISO 11137 is desirable.
- Chemistry/Microbiology/Dosimetry Lab experience is desirable.
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