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Job Details

Senior Scientist - CMC Bioassay Development

Company: Clinical Professionals Ltd
Location: Cambridgeshire
Reference: J32075
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: £45k - £60k

Job Summary:

Senior Scientist - CMC Bioassay Development This role is a Scientific Professionals exclusive with a market-leading biopharmaceutical company, based in Cambridge who focus on monoclonal antibody therapeutics.

Requirements:

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

Apply for this job: Senior Scientist - CMC Bioassay Development

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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