This is an 11-month contract initially.

Purpose

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 BioNX 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.

Responsibilities

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 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 teamworking ability to work with global and interdisciplinary teams.

Requirements

A degree qualification in a relevant field (Science/Technical). An Advanced Degree (MSc) qualification is desirable.
A minimum of 2 years’ experience working in a relevant academic or industry field.
Knowledge of Environmental Testing, WFI testing.
A 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.
Ability to think logically and be proactive under pressure.
Ability to work as part of a team and on own initiative in a constructive manner.
Effective communicator and to be able to share and communicate that knowledge through training other analysts.