This is an 11 month contract role.
The Analytical Sciences (AS) group requires a Technical Specialists with strong analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team. The successful candidate will be responsible for assisting in the effective and efficient running of analytical projects and will be active members within the wider Technology team to provide 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 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.
• 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.
• 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.
• 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.
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