The successful candidate will be required to demonstrate a high level of technical leadership, collaboration, and coaching to facilitate the team in becoming a high-performance organisation 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 be required to deliver technical excellence for analytical method stabilisation and process optimisation studies which will deliver and maintain process robustness.
* Good knowledge of working practices required for working in a Microbiology laboratory (e.g. Bioburden, Endotoxin, Sterility testing etc.)
* Support assay optimisation/investigations within the Microbiology area
* 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 through the use of project management tools
* Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other Sites and contract laboratories as required.
* Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing 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 Qualifications
* BSc in a relevant Science discipline Ph.D./M.Sc. qualification (Science)
* Experience with leading analytical method validations/Verifications
* 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.
* Knowledge of and experience in applying Six Sigma and Lean methodologies
* Equipment commissioning and qualification.
* Management Professional (PMP) Evidence of Continuous Professional Development.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists