- BBBH778796 Mar 29, 2021 Competitive
Excellent opportunity for a Bioassay Technical Specialist. Please apply below or contact firstname.lastname@example.org for more information.
Bioassay Technical Specialist
A Technical Specialist is required to join the Analytical Sciences group within a global Biopharma based in Cork.
The successful candidate will be responsible for assisting in the effective and efficient running of analytical projects and will provide Technical support, guidance and expertise.
A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for a number of analytical transfers, method development, method qualifications, and small scale process optimisation studies.
The Scientific Technical Specialist provides in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. This role is responsible for all aspects of method and equipment validation, assisting in the effective and efficient running of the method, equipment validation and small scale optimisation operations programs. In addition, providing on-going technical support to the site in the area of contamination control. Works with moderate work direction and is skilled and knowledgeable to the position.
- Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
- Experience in Method Validation/ Method Transfers would be desirable
- Participate in continuous improvement initiatives, including method optimisation and troubleshooting
- Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
- Lead and Participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
- Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
- Adhere to highest quality standards
- MSc/BSc. qualification (Science)
- At least 3 years' industry experience working with ELISA/Bioassay in a QC/Analytical role group.
- High level written and verbal communications with advanced PC skills.
- Self-motivated and ability to work as part of a team with good project management skills.
- Demonstrated ability to fully realize improvement initiatives.
- Demonstrated successes in a team environment, such as project teams, problem solving teams etc.
- Stakeholder management of multiple decision makers, corporate colleagues, cross functional teams.
- Desired Qualifications/Experience: Minitab, Softmax Pro, JMP, Trackwise
- Project management qualification is desirable such as, Project Management Professional (PMP) Evidence of Continuous Professional Development.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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