Fuse Science Recruitment has an exciting opportunity for an experienced Scientist within CMC Development to join a cutting-edge biotechnology company in Cambridgeshire, this is a permanent position with competitive salaries and benefits package. Check out the full job specification below:

The Role

As the CMC Analytical Development Scientist you’ll support the development of portfolios including internal analytical testing and support of outsourced analytical activities at CROs and CDMOs

• Develop and utilise novel analytical techniques to support lead-candidate developability, protein characterisation, and identification of potential Critical Quality Attributes (pCQAs) for the Development Pipeline
• Independently and proactively support in-process testing, product quality analysis and forced degradation studies (determining mechanisms of degradation or protein-protein interactions as required)
• Represent the CMC Analytical Development Function as a Subject Matter Expert (SME) on internal and external project teams
• Lead, coach and mentor the internal scientific teams engaged in analytical support, to facilitate product candidate molecule development
• Produce and maintain CMC Analytical Development records, SOPS and documentation to support regulatory submissions and inspections.
• Maintain awareness of and ensure compliance with policies and cGMP procedures relating to outsourced cGMP manufacture
• Support CMC pre-formulation development and stability evaluation
• Design and execute Clinical compatibility studies

You

Ideally, you’ll have a PhD or equivalent and relevant industry experience of biotherapeutics analyticsl development and characterisation across multiple technology platforms including chromatography, electrophoresis, biophysical and MS Characterisation.

Extensive experience of protein analytical/physiochemical strategies and characterisation of complex biological products e.g. antibody/Bi-specifics along with strong communication skills, with the ability to build strong relationships with key individuals at CMC Suppliers and interact effectively in multidisciplinary teams both internally and externally.

Package

Competitive salaries and a generous benefits package are on offer including Pension, Private Health and Dental, Life Insurance, Bonus and Share Options. There are also great opportunities for career progression within this expanding company.

Company

A leading Biotechnology Company who are developing next generation Humabody therapeutics derived from a unique transgenic platform all focused to build an exciting portfolio of novel oncology products in areas of high unmet need.

Apply Now

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