Level : Scientific Deadline : 29 / 06 / 2018 23 : 59 Hours : 35.00 Benefits : Excellent range of benefits Job Type : Permanent
We are looking for a Senior Research Scientist to develop and qualify novel bioanalytical methods for immunogenicity testing, pharmacokinetics and soluble biomarkers as required to support the progress of Kymab therapeutic antibody candidates through pre-
clinical and clinical development.
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
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.
Relevant BSc or equivalent as a minimum, MSc or PhD an advantage
Experience within regulated (GLP & GCP) large molecule bioanalysis
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.
Experience in outsourcing to specialised bioanalytical CRO’s
Prior experience in a leadership position and / or line management
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.
Competency in data processing software packages such as SoftmaxPro, MSD Discovery Workbench, GraphPad Prism and standard Microsoft Office applications.