Description:
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.
Demonstrate a high level of technical leadership, collaboration, coaching and mentoring to facilitate the team in becoming a high performing organisation and ensuring timely delivery of projects. Central to this objective will be the active engagement and communication with all internal and external stakeholders.
Analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories.
- 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 area
- Analytical Technology Transfer
- Preparation 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
Requirements
- BSc in a relevant Science discipline
- At least 4 year experience with ELISA/ Bioassays and leading analytical method validations
- Self-motivated and ability to work as part of a team with good project management skills
- High level written and verbal communications with advanced PC skills
- Knowledge and experience of operating in a development and commercial lab environment
- Project management or qualifications such as, Project Management Professional (PMP)
- Knowledge of and experience in applying Six Sigma and Lean methodologies,
- Equipment commissioning and qualification.