Senior Scientist, Viral Clearance

About the company

My client is a big Pharmaceutical Company in Singapore.

Your tasks

• Lead the planning, execution, interpretation, analysis, documentation, and reporting of viral clearance studies in compliance with applicable regulatory guidelines, including ICH Q5A and relevant EMA guidance.
• Design and conduct hands-on laboratory studies, including small-scale control runs, virus-spiked studies, virus inactivation assessments, and virus reduction filtration evaluations.
• Set up and operate chromatography, ultrafiltration, and dead-end filtration systems in accordance with approved protocols and GMP requirements.
• Review and interpret raw data to generate robust process knowledge and high-quality datasets suitable for regulatory inspections.
• Author study protocols, technical reports, and regulatory documentation, and support interactions with regulatory agencies.
• Supervise project teams, lead troubleshooting activities, and resolve technical challenges during study execution.
• Build and maintain strong working relationships with external customers, contract testing laboratories, and internal stakeholders.
• Communicate study progress, results, and technical findings effectively through written reports, teleconferences, and face-to-face meetings.
• Collaborate with site and global project teams to manage multiple studies, coordinate project milestones, and ensure timely delivery of project activities.

Requirements

What we are looking for

• Degree/PhD in Biological Science/Engineering as appropriate for area of expertise.
• 4-7 years’ experience or 2-5 years and a PhD with experience gained in a lab either in industry or academia, or via an industry work training programme.
• Practical laboratory experience in virus clearance studies, study directing and project management is required.
• Developing a detailed understanding of the scientific rationale behind one or more technical areas involved in the development of biopharmaceuticals.
• The final role offered will be commensurate with the candidate’s experience.
• Understanding of cGMP regulations and quality management is required.

How to apply

Director Recruitmatic Pte. Ltd. (22S1186)

Other

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