Senior Scientist - CMC Bioassay Development

Recruiter
Clinical Professionals Ltd
Location
East Horsley
Posted
31 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior Scientist - CMC Bioassay Development Permanent Cambridge £45k - £60k This role is a Scientific Professionals exclusive with a market-leading biopharmaceutical company, based in Cambridge who focus on monoclonal antibody therapeutics. They"e;re looking for an experienced senior scientist to develop their in-house potency assay capabilities in support of their CMC drug development. Duties/Responsibilities: - Develop & optimise cell based biological assay methods, cell lines & reagents for use as potency assays in outsourced GMP product release & stability testing - Assess discovery based bioassay methods for potency assays for GMP product release & stability testing - Manage the transfer of bioassays to external CMOs, reviewing establishment & validation plans & monitor output & performance - Author regulatory submissions - Support project teams throughout product development Requirements: - PhD desirable with relevant industry experience of potency bioassay development & validation or BSc/MSc with significant experience of potency bioassay development & validation - Project Management experience, across multiple, simultaneous projects - Experience in developing therapeutic monoclonal antibody potency assay methods (target binding/agonism, ADCC, etc.) and relevant microplate platforms (fluorescence, luminescence, MSD, spectrophotometric, cell cultures) - GMP knowledge - Line management/matrix management - Experience of regulatory submissions & tech transfer If however, you do not feel that this is the right role for you, please forward these details on as we do have a generous referral scheme in place. Please note, due to the high volume of applications, if you do not receive a response within 48 hours, your application has not been successful on this occasion. CMC, bioassay, development, antibody, biological assay, cell line, reagent, potency assay, GMP, discovery, in vitro, target binding, target agonism, ADCC, microplate, fluorescence, luminescence, MSD, spectrophotometric, cell culture, regulatory submission, tech transfer

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