Senior Scientist, Viral Clearance

My client is a big Pharmaceutical Company in Singapore.

What you will do:

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.

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.

Kris Lam (R1983356)

Director

Recruitmatic Pte. Ltd. (22S1186)

2 Venture Drive #14-02

Vision Exchange S608526