MSD Senior Scientist- External Large Molecule Analytical Sciences 

Ireland 

512242825

Job Description

Key Responsibilities:

• Provide analytical oversight and on site presence while collaborating with our external providers (biologics and vaccines).
• Build and sustain relationships with external partners and internal departments (operations, technology, procurement).
• Support departmental teams with facility start-up and ongoing operational activities.
• Collaborate with Global Analytical Working Groups and Subject Matter Experts (SMEs).
• Drive initiatives for continuous improvement in testing quality through best practices and proactive tools.
• Identify and resolve analytical issues and deviations from testing labs, ensuring accurate test results and project timelines.
• Prepare external testing sites for inspections by regulatory agencies (e.g., FDA, EMA, PMDA).
• Author and review technical documents for Process Performance Qualification (PPQ) and regulatory inquiries.

Required Skills and Experience:

• Analytical Product Lifecycle: Proficient in lifecycle activities (development, validation, transfer) for large molecule analytical platforms (e.g., ELISA, HPLC, CE).
• Biologics Analytical Technology Knowledge: Understanding of techniques such as bioassays (e.g., ELISA, cell-based methods), chromatography (HPLC, UPLC), and biochemistry methods including in process controls.
• Biopharmaceutical Industry Experience: Background in the biopharmaceutical sector, particularly in the commercialization of biologics or vaccines, technical operations, or quality control.
• Regulatory Knowledge: Understanding of regulatory requirements and guidelines (ICH, USP, Ph. Eur., JP).
• Organizational and communication Skills: Strong project management abilities to manage multiple tasks and projects effectively

Current Contingent Workers apply

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