An amazing opportunity has arisen for a Scientist, within the Microbiology Laboratory, at a biopharmaceutical company in Dunboyne. The successful candidate will contribute to the establishment and day-to-day operations of their laboratory and will work valuate and implement novel equipment, process and next generation technologies.
- Participate in the start-up of operations within the new laboratory facility which will include support of equipment qualification PQ protocols, documentation generation such as SOP’s, Work instructions authoring and review as well as contributing to lab and process work flow establishment.
- Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
- Ability to organise and establish testing schedules and adhere to deadlines.
- Support introduction of novel, innovative solutions supporting the microbiology lab start up of biologics within the facility.
- Execute in-process and drug substance analysis studies to support manufacturing, including supporting laboratory scale studies.
- Support technical assessments on new products in partnership with global technical teams.
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- To participate in lean lab methodologies and deviation writing.
- Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
Qualifications & Experience:
- A degree qualification in a relevant field (Science/Technical), an Advanced Degree (MSc) qualification is desirable.
- A minimum of 2 years experience working in QC environment
- Knowledge of Environmental Testing, WFI testing.
- Knowledge of method transfers, scheduling would be highly desirable for
- Bioburden testing and in process testing for Biologics.
- Technical knowledge with Biologics drug substance analytical testing.
- Knowledge of design and operation of automated systems such as GLIMS,
- Trackwise and E-logs would be desirable.
To apply for this job email your details to email@example.com.