MSD Senior Scientist Analytical R&D - Bioassay 

Ireland 

101385739

Job Description

Role profile:

• Review execution of analytical method validations and transfers (among different sites, and between the company and CROs) and write technical protocols and reports.
• Review and execution of analytical testing of drug substance release, stability, and characterization for biologics under GMP/GDP.
• Analyse and optimize current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.
• 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 Biologics AR&D at Dunboyne.
• Review and approval of analytical methods, SOPs, and other documentation.
• Technical Troubleshooting & Optimisation to support seamless method qualification.
• Support Quality Events to ensure execution in Biologics AR&D is compliant to GMP standards.
• Facilitate introduction of Cell Based Assay methods to the bioassay laboratory, including but not limited to the implementing of processes, onboarding of equipment, authoring of SOPs, and establishing training.
• Works in accordance with applicable internal company regulations: safety, health, and environmental protection.
• Coaching and mentoring for scientists within the department.
• Ensure correct and appropriate maintenance of the equipment, including calibration and qualification.

Your profile:

• Ph.D. in analytical chemistry/biochemistry or related field or M.S. with a minimum of 3 years of experience in the Biopharmaceutical Industry or Bachelor with 7 years of experience in the Biopharmaceutical Industry.
• GMP working experience and a working knowledge of regulatory requirements.
• Expertise in functional cell-based assays, binding assays e.g. ELISAs, tissue culture, antibody biochemistry and aseptic techniques.
• Ability to review and/or execute the qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.
• Knowledge of Analytical Methodologies and sound scientific understanding of Critical Quality Attributes as well as data analysis and statistics for setting specifications.
• Expertise in method validations and technology transfers.
• Effective organizational and multi-tasking skills with strong oral and written communication skills.
• Team player with ability to support peer to peer coaching and lead technical discussion with subject matter experts, Operations, Quality.
• Applies strong scientific and technical knowledge to shape and deliver on pipeline innovation.
• Leverage broad expertise to drive strategic, therapeutic, regulatory, and scientific goals.
• Partners with Management to develop and execute scientific and enterprise strategy.
• Models and inspires a culture of collaboration, diversity & inclusion.
• Strong commitment to coaching, mentoring, and training scientists.
• Understanding of protein degradation mechanisms and link between analytical methodologies for analysis.
• Understanding of current manufacturing processes.
• Experience in ELISA methods, PCR, and analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion proteins, etc.).
• Certified in Lean Six Sigma or experience in Quality by Design.

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

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