Purpose This individual will work closely with the Enabling Technology and Engineering group to leverage Process Automation knowledge as well as the Analytical group to enable the adoption of Process Analytical Technology (PAT).
The?Microbiology Lab Operations group with work closely with Operations to understand facility fit and will be able to flex resources as needed.?
This is a shift-based role (primarily extended days but it is subject to business needs) Responsibilities Drive laboratory operations within the new laboratory facility which will include oversight of equipment qualification (PQ), documentation generation and SME review of SOPs, Work instructions as well as contributing to lab and process establishment.
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.
Maintaining and release of laboratory stock, ordering laboratory consumables where required.
Active participation in functional meetings, leading of departmental and cross-functional meetings where required.
Participation in internal and external audit and inspection activities and ensure permanent inspection readiness.
Support and drive site safety & ways of working culture demonstrating respect and appreciation for diverse populations..
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.
Support introduction of novel, innovative solutions, collaborating with the global Microbiology Center of Expertise and participating in lean lab methodologies.
Ability to organise and establish testing schedules and adhere to deadlines.
Build team effectiveness skills, learn to promote team success through own actions and by Be flexible to support changing business needs, (e.g.
Infrequent out of hours testing support for exceptional circumstances).
Be able to share and communicate that knowledge through training other analysts & maintain timely training completion Qualifications A degree qualification in a relevant field (Biological Sciences/ Engineering), preferable for background in microbiology, An Advanced Degree (e.g., MSc) qualification is desirable.
3+ years experience working in a relevant industry field.
Ability to work as part of a team and on own initiative in a constructive manner.
Technical Knowledge with Biologics drug substance manufacturing and microbiological testing techniques.
Ability to think logically and be proactive under pressure.
Effective communicator.
Working arrangements 4 day on / 4 day off, 7 day rolling shift on extended days only ( 7am to 7pm).
This will incur a 20% premium.
An example would be Monday to Thursday 1 week, off Friday, Sat, Sun, Mon, back in Tuesday to Friday