Position Title: Associate Scientist – Sample Management
Department: Discovery. Product Development and Supply; BioTherapeutics Development & Supply Analytical Development – Clinical Release and Stability (DPDS, BTDS-AD)
Report to: BTDS-AD Laboratory Management
Position Summary
Global Clinical Release & Stability is a department of Discovery. Product Development and Supply; BioTherapeutics Development & Supply Analytical Development – (DPDS, BTDS-AD). The department is responsible for Clinical Release and Stability Testing for Drug Substance and Drug Product, and Stability Lifecycle management.
Main duties and responsibilities
- Responsible for coordinating activities in relation to laboratory batch release.
- Responsible for coordinating activities in relation to clinical reference materials.
- Responsible for coordinating activities in relation to stability programs.
- Daily management of the routine sample management operations/LIMS Stability Module.
- Responsible for the management of stability inventory.
- Ensure all activities follow SOP’s/WI’s and protocols where appropriate and are performed in compliance with regulatory guidelines.
- Perform sample management activities according to local procedures and processes in a timely and organized fashion.
- Organize stability inventory and maintain stability chambers.
- Coordinate receipt and distribution of samples throughout the laboratories.
- Perform other duties as designated by Laboratory Management.
- Develop subject matter expertise on assigned role.
- Use of laboratory software such as LIMS, SAP, SDMS, Trackwise, etc.
- Contribute to proper use, calibration, and maintenance of laboratory equipment.
- Record all laboratory data in accordance with cGMP and local procedures.
- Perform data review.
- Keep up to date with existing and new SOP’s and official documentation.
- Perform investigations, where required, for deviations, laboratory investigations etc.
- Independently write/revise SOP’s or other official documentation and reports, when required.
- Execute independently and/or as part of a team, assigned projects/tasks.
- Train/coach other/new personnel.
- Lead/participate in lean innovation and continuous improvement projects