Location:
Brinny, Ireland
Flexible hybrid role:
(3 days on, 2 days off), no shifts
Type of contract:
11 - month contract - maternity backfill
Our client:
Leading biopharmaceutical company that conducts research, development, and high volume manufacturing of medicines and vaccines for its global network
Position Summary
The successful candidate will be responsible for assisting in the effective and efficient running of analytical projects and will be an active member within the wider team providing technical support, guidance and expertise to ensure the success of the team. A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for analytical tech transfers, method support and troubleshooting, equipment validation and investigation support.
Key Responsibilities
* 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 and participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site
* 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.
* Adhere to highest quality standards
Qualifications
* BSc in a relevant Science discipline
* 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
* Stakeholder management of multiple decision makers, corporate colleagues, cross functional teams
* High level written and verbal communications with advanced PC skills
* Knowledge and experience of operating in a development and commercial lab environment
* Evidence of Continuous Professional Development
Desired Qualifications/Experience:
* Ph.D./M.Sc. qualification (Science)
* Experience in Softmax pro template management
* Equipment commissioning and qualification.