Senior Scientist; QC

Do you want to play a key role in advancing innovative biologic therapies through robust quality control science?

Are you ready to lead assay transfer and validation activities that support product development and commercial readiness?

Do you enjoy mentoring colleagues while helping build and strengthen quality control capabilities within a growing organisation?

Fraser Dove International is partnering exclusively with a pioneering biotechnology organisation. Operating in the United States, they are committed to developing innovative biological therapies that improve patient outcomes through scientific excellence and quality-driven operations.

Our client is seeking a technically accomplished leader to drive assay transfer, validation, and quality control excellence across biologics development programmes.

Your objectives:

• Successfully lead the transfer and validation of analytical methods from Research and Development (R&D) into Quality Control (QC) while maintaining compliance with regulatory and quality requirements.
• Strengthen QC laboratory capabilities through technical leadership, process improvement, and the implementation of robust testing strategies.
• Support the development of a high-performing quality culture by mentoring colleagues and collaborating effectively with cross-functional stakeholders.

What you will do:

• Lead assay transfer and validation activities from R&D into QC laboratories.
• Author, review, and approve validation protocols, reports, and supporting documentation.
• Provide technical expertise across potency assays, ELISA, automated western blot, cell-based assays, molecular biology methods, and particle tracking analysis.
• Support cell banking, analytical testing, and quality control laboratory operations.
• Identify process gaps and implement improvements to strengthen QC systems and capabilities.
• Mentor and coach junior scientists while providing technical oversight on key projects.
• Collaborate closely with Regulatory Affairs, Technical Operations, Manufacturing, and Development teams to ensure successful program execution.

What you will bring:

• Demonstrated experience supporting biologics quality control activities within a GMP environment.
• Proven success leading assay transfer and validation projects.
• Experience authoring validation protocols, reports, and technical documentation.
• Strong technical expertise across biologics analytical methods and bioassays.
• Excellent communication, stakeholder management, and influencing skills.
• Bachelor of Science (BSc) in Biology, Biochemistry, Molecular Biology, Biotechnology, or a related scientific discipline.
• Master of Science (MSc) or Doctor of Philosophy (PhD) qualification is desirable.