Orion Group are sourcing a Technical Specialist, Bioassay (hybrid) on behalf of our Multinational Biopharmaceutical Client on an initial 11-month contract basis.
This position requires someone with strong analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories. The successful candidate will be responsible for leading the effective and efficient running of Analytical Bioassay and ELISA methodologies both globally and locally, Analytical Method Transfers, Validations, Investigations, and Change Control. In addition, the successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytical Sciences group.
The successful candidate will demonstrate a high level of technical leadership, collaboration, coaching, and mentoring to facilitate the team in becoming a high-performing organization and ensuring timely delivery of projects. Central to this objective will be the active engagement and communication with all internal and external stakeholders. A high level of innovation, enthusiasm, and drive will also be required to deliver technical excellence for analytical methods.
What you will do: Good knowledge of working practices required for working in a Bioassay laboratory (e.g., ELISA, cell biology, cell culture, protein biochemistry, etc.)Support assay optimisation/investigations within the Bioassay areaAnalytical Technology TransferPreparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.Lead the delivery of projects whilst adhering to project timelines using project management tools.Lead cross-functional problem-solving teams for troubleshooting and investigations within local Quality, other Sites within the network, and contract laboratories as required.Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and lifecycle management of Bioassays.Engage in ongoing Bioassay performance monitoring.Prepare, review, and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc.Collaborate with internal partners (i.e., other sites, R&D) and externally with CROs.What skills you will need: BSc in a relevant Science disciplineExperience with ELISA/Bioassays and leading analytical method validationsSelf-motivated and ability to work as part of a team with good project management skillsHigh level written and verbal communications with advanced PC skillsKnowledge and experience of operating in a development and commercial lab environmentProject management or qualifications such as Project Management Professional (PMP)Desired Qualifications/Experience: Ph.D./M.Sc. qualification (Science)Knowledge of and experience in applying Six Sigma and Lean methodologiesEquipment commissioning and qualification.
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