Job Overview
We are seeking a highly skilled analytical professional to join our team. This exciting opportunity will involve driving laboratory operations within a state-of-the-art facility, overseeing equipment qualification, documentation generation and SME review of SOPs, work instructions and contributing to lab and process establishment.
This role offers the chance to work on high-profile projects, collaborate with global experts and drive innovative solutions. As an analytical scientist you will be responsible for reviewing and/or leading trending and reporting of laboratory data, maintaining oversight of review metrics, collating and analysing end of quarter and year reports for all raw data generated.
Additional responsibilities include maintaining and releasing laboratory stock, ordering laboratory consumables as required, active participation in functional meetings and leading departmental and cross-functional meetings where necessary. You will also support and drive site safety & ways of working culture demonstrating respect and appreciation for diverse populations.
Key Responsibilities:
1. Drive laboratory operations within the new laboratory facility which will include oversight of equipment qualification (PQ), documentation generation and SME review of SOP's, Work instructions as well as contributing to lab and process establishment.
2. Review and/or lead, trending and reporting of laboratory data, to support batch release, maintain oversight of review metrics, to collate and analyse end of quarter and year reports for all raw data generated.
3. Maintaining and release of laboratory stock, ordering laboratory consumables where required.
4. Active participation in functional meetings, leading of departmental and cross-functional meetings where required.
5. Participation in internal and external audit and inspection activities and ensure permanent inspection readiness.
6. Support and drive site safety & ways of working culture demonstrating respect and appreciation for diverse populations.
7. Perform supporting GMP activities & troubleshooting for general lab operations, EM, Facility testing as required, and execute in-process and drug substance analysis studies & lead/participate in laboratory projects.
8. Support introduction of novel, innovative solutions, collaborating with the global Microbiology Center of Expertise and participating in lean lab methodologies.
9. Ability to organise and establish testing schedules and adhere to deadlines.
10. Build team effectiveness skills, learn to promote team success through own actions and by.
11. Be flexible to support changing business needs, (e.g. Infrequent out of hours testing support for exceptional circumstances).
12. Be able to share and communicate that knowledge through training other analysts & maintain timely training completion