Senior Research Scientist, Bioanalytical Development
Kymab
Babraham Research Campus, Cambridge, UK
31d ago

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.

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
  • 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.
  • Essential :

  • 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.
  • Preferred :

  • 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.
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