21580 – Analytical Sciences Technical Support – Cork Contractor

Purpose

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, equipment validation and small-scale process optimisation studies.

They will provide 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.

Responsibilities

• Lead and participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
• Knowledgeable in protein chemistry and analytical techniques in a Chemistry Separations laboratory (e.g. HPLC, CE and protein biochemistry etc.), Method validations, method transfers and Equipment qualifications in a GMP environment.
• Perform laboratory experiments required to deliver on project timelines.
• 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.
• Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
• Adhere to highest quality standards.

Requirements

• BSc/MSc. qualification (Science)
• At least 3 years’ industry experience working with chemistry techniques (e.g. HPLC, CE and protein biochemistry etc.) in a QC/Analytical role group.
• Demonstrated successes in a team environment, such as project teams, problem solving teams etc.
• 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.
• Desired Qualifications/Experience: Empower3, Astra, SAP.
• Demonstrated ability to fully realize improvement initiatives.
• High level written and verbal communications with advanced PC skills.
• Project management or qualifications such as, Project Management Professional (PMP)
• Evidence of Continuous Professional Development.