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Permanent Positions

Manager – Bioanalytical Development
Cambridge, East Anglia

Manager – Bioanalytical Development
We have a new vacancy in our expanding Development team for a Bioanalytical Development Manager to take responsibility for the development, qualification and validation of pharmacokinetic, immunogenicity and soluble biomarker assays required to support the progress of therapeutic antibody candidates through pre-clinical and clinical development. This is a full-time permanent position in the Cambridgeshire area.

The Role
Core duties will include:
 To efficiently manage bioanalytical development activities for multiple projects, primarily through outsourced studies but also including some limited oversight of in-house laboratory activities
 To work within development project teams and take responsibility for defining and managing bioanalytical support for specific projects
 To identify appropriate external contractors or service providers for each work package and ensure that the pre-clinical and clinical project requirements are met by:
 Contractual engagement according to the client’s SOPs
 Defining study protocols, work plans, analytical methods and costs to fit project timeline and budget
 Monitoring and management of contractor performance to ensure study completion according to agreed quality standards, timelines and costs
 Review and finalisation of bioanalytical data, study documentation and reporting
 To keep up to date with relevant regulatory guidance 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

Experience and Qualifications:
To apply for this role, you will need the following experience and qualifications:
 Relevant BSc. or equivalent as a minimum, PhD an advantage
 Significant managerial experience in regulated (GLP & GCP) large molecule bioanalysis, including immunogenicity analysis
 Experience in outsourcing to specialised bioanalytical CRO’s a distinct advantage
 Applicants from both industry and CROs welcomed
 Technical expertise in designing, optimising and troubleshooting large molecule bioanalytical methods for pre-clinical and clinical drug development studies using platforms such as ELISA, MSD-ECL, DELFIA, AlphaLISA, Gyrolab
 Up to date knowledge of current industry bioanalytical standards and relevant regulatory PK, immunogenicity and biomarker guidance
 Excellent communication and management skills allied with ability to control contractors and collaborators
 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
 Working knowledge of FACS analysis an advantage
 Competency in data processing software packages such as SoftmaxPro, MSD Discovery Workbench, GraphPad Prism and standard Microsoft Office applications

How to apply
To apply for this role, simply apply to the advert, or alternatively you can email your CV to info@s3science.com.

All successful candidates are subject to S3 Science’s stringent security checks.

S3 Science is proud to be an equal opportunities employer and is committed to creating a diverse environment. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status.

Salary: Competitive
Date Posted: 07/09/2017
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