This role is an 11 Month Contract with a view to extension.
The Lab Operations group with work closely with Operations to understand facility fit and will be able to flex resources as needed. The group will also have close collaborations with the Company’s Enabling Technology. As well as contributing to the establishment and day-to-day operations of our laboratory you will work across the site and network as part of a diverse and interdisciplinary team to evaluate and implement novel equipment, process, and next-generation technologies to keep Our Company at the forefront of innovation in development and manufacturing of biologics.
• 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 SOPs, Work instructions authoring and review as well as contributing to lab and process workflow 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 troubleshooting and problem-solving skills as well as influencing, collaboration skills, and teamwork ability to work with global and interdisciplinary teams.
• A degree qualification in a relevant field (Science/Technical). An Advanced Degree (MSc) qualification is desirable.
• A minimum of 2 years of experience working in a relevant academic or industry field.
• Knowledge of Environmental Testing, and WFI testing.
• A knowledge of method transfers, and scheduling would be highly desirable for Bioburden testing and in-process testing for Biologics.
• Technical knowledge with Biologics drug substance analytical testing.
• Knowledge of the design and operation of automated systems such as GLIMS, track wise, and E-logs would be desirable.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative constructively.
• Effective communicator and be able to share and communicate that knowledge through training other analysts
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