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Job Details

Snr Research Scientist Bioanalytical Development

Company: Clinical Professionals Ltd
Location: Cambridgeshire
Reference: JO-1805-409214
Closing Date: 29 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

They are looking to recruit an outstanding Senior Research Scientist to develop and qualify novel bioanalytical methods for immunogenicity testing, pharmacokinetics and soluble biomarkers.

Requirements:

If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders.

The company is engaged in the discovery and development of human monoclonal antibody therapeutics using novel monoclonal antibody therapeutic platforms

They are looking to recruit a Subject Matter Expert in novel bioanalytical assays for preclinical & clinial immunogenicity testing & pharmacokinetics. This role is suited to a Research Scientist through to a Group Leader level of seniority.

Key Responsibilities:
• Lead the development of novel bioanalytical assay methods at the bench level for preclinical and clinical immunogenicity testing and pharmacokinetics

• Assist with the development of bioanalytical methods for soluble biomarkers

• Provide technical expertise and mentor current lab based Bioanalytical Scientists & Research Associates

• Ensure methods are designed to meet current industry and regulatory guidance

• Contribute technical expertise during the transfer of methods to third party contract manufacturing organisations

• Evaluate and implement new technologies and platforms as required

• Authoring of relevant sections of regulatory submissions

• Provide support to research project teams throughout the product development process

• Review and finalisation of in-house bioanalytical data, study documentation and reporting

• To keep up to date with relevant regulatory guidance’s and bioanalytical industry best-practice applicable to GLP, GCP and GCLP.

• To assist with compilation and documentation of relevant bioanalytical documents to support successful IND or CTA filings.

• To communicate progress and identified risks and issues arising on bioanalytical matters.

Requirements:

Education and Experience

Relevant BSc. or equivalent experience as a minimum, Masters or Ph.D an advantage.

Ideal candidate would have experience in regulated (GLP & GCP) large molecule bioanalysis and also some experience in managing or training bioanalytical bench scientists (depending on the level).

Experience in outsourcing to specialised bioanalytical CRO’s an advantage.

Applicants from both industry and CROs welcomed.

Skills and Knowledge

Proven expertise in designing, optimising and trouble-shooting novel pre-clinical and clinical bioanalytical methods for therapeutic drug development studies using platforms such as ELISA, MSD-ECL, DELFIA, Gyrolab.

Up to date knowledge of current industry bioanalytical standards and relevant regulatory PK, immunogenicity and biomarker guidances.

Excellent communication and management skills allied with ability to line manage laboratory scientists.

Highly organised, able to prioritise work, work well under pressure and meet deadlines

Exceptional attention to detail for review of bioanalytical data

Ability to work in a flexible, collaborative style with colleagues and teams within the company, as well as with external advisors, service providers and collaborators including consultants, CROs and partners in strategic R&D collaborations.

Competencies
Competency in data processing software packages such as SoftmaxPro, MSD Discovery Workbench, GraphPad Prism and standard Microsoft Office applications.

Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: matt@scientificprofessionals.com . We endeavour to come back to you within 24 hours of CV submission.

Apply for this job:  Snr Research Scientist Bioanalytical Development

Contact Information:

Address:  Clinical Professionals Ltd
33 Blagrave Street,
Reading
RG1 1PW
England
Tel:  0118 959 4990
Fax:  0118 956 0607
Website:  Visit Our Web Site

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