Position: Senior Scientist CMC – Bioassay Development
Location: Cambridge
Salary: Competitive

The Role

A leading Biopharmaceutical Company are looking to recruit Senior Scientist to develop in house biological assay capabilities in support of outsourced CMC activities.

Responsibilities
• Develop and optimise cell based biological assay methods, cell lines and reagents for use in GMP product release and stability testing
• Assess Discovery based bioassay methods for their utility as potency assays for GMP product release and stability testing
• Manage the transfer of suitable bioassays to third party contract manufacturing organisations
• Ensure methods are designed to meet current industry and regulatory guidance
• Evaluate and implement new technologies as required
• Authoring of relevant sections of regulatory submissions
• Contribute to on-going MOA assay development within the group
• Provide support to project teams throughout the product development process
You

Ideally, you’ll have a BSc, MSc or PhD in an in vitro cell based subject and have significant relevant experience in bioassay development and validation for use in GMP and tech transfer.

Experience in therapeutic monoclonal antibody potency assay methods (target binding/agonism, ADCC) and associated microplate platforms (luminescence, MSD, spectrophotometric) is also essential.

Package

Competitive salaries and a generous benefits package are on offer including Pension, Private Health and Dental, Life Insurance, Bonus and Share Options.

Company

A leading Biopharmaceutical company who are focused on the discovery and development of fully human monoclonal antibody drugs across several therapeutic antibody programmes in Immune-oncology, auto-immunity, haematology and infectious disease.

Apply Now

To be considered for the Senior Scientist in CMC Bioassay Development please send your CV to Natasha Robbins at Fuse Science Recruitment via the apply now button.