MSD Raw Materials Research Senior Specialist 

Ireland 

272209732

Job Description

The Biologics Analytical Research & Development (BARD) department in Dunboyne is seeking applications for a

Tasks and responsibilities include but are not limited to.

• Ownership of BARD responsibilities for raw materials at the site.
• Lead raw material programs for all new biologics coming to site.
• Ensuring raw material testing proposed is appropriate, GMP, verified, tested, released as per the quality management system.
• Review execution of analytical method validations and transfers (among different sites, and between the Company and CROs) and write technical protocols and reports.
• Collaborate with a global network of scientists to streamline and platform scientific methods entering Dunboyne.
• Propose Raw Material testing and specifications, Generation of Global test specifications, ensuring testing is qualified to GMP either internally or externally.
• Manage relationship with the testing laboratories & partner with Warehouse, supply chain, quality to ensure raw materials are released in accordance with GMP & internal procedures.
• Oversight of the Raw Material Systems Build & Maintenance on Comet & GLIMS.
• Author & oversee Raw Material Related Testing Investigations.
• Analyse and optimize current IT lab System business processes for the laboratories and support implementation activities of the technologies and methodologies.
• Works in accordance with applicable internal company regulations: safety, health, and environmental protection.
• Top of Form.

Your profile:

• M.S in analytical chemistry/biochemistry or related field with 3 years of experience or B. S with a minimum of 7 years of experience in the Pharmaceutical Industry.
• GMP working experience and a working knowledge of regulatory requirements.
• Knowledge of Analytical Methodologies and sound scientific understanding with focus on liquid chromatography and IR spectroscopy as well as data analysis and statistics for setting specifications.
• Effective organizational and multi-tasking skills with strong oral and written communication skills.
• Team player with ability to support peer to peer coaching.
• Author technical protocols and reports as required.
• Understanding of current manufacturing processes.
• Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required.
• Expertise in method validations and technology transfers.

So, ifyou are ready to:

Current Contingent Workers apply

Not Applicable

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