Oxford BioMedica (UK) Limited

Director, Analytics, Process R&D

06 Apr 2021
04 May 2021
R & D , Scientific
Full Time
Contract Type
Experience Level
Senior Management

Our employees are able to develop their careers in exciting new medical technologies, and so can you.

Oxford Biomedica’s Process R&D team consists of experienced scientists and engineers that have extensive expertise in all aspects of upstream and downstream development.  PR&D take processes from the laboratory “bench” scale and apply process expertise and engineering fundamentals for delivery to Manufacturing.

We are currently recruiting for a Director, Analytics to join the team.  The purpose of this role is to lead multi-disciplinary teams to provide timely delivery of Process R&D analytical services, ensuring timelines are met whilst maintaining compliance with the appropriate quality and safety guidelines and sustaining the high quality work conducted within PR&D at OXB

Your responsibilities in this role would be:

  • Accountable for the effective performance of the Process R&D Department, with tactical focus on ensuring all Process R&D analytical testing is scheduled and results are delivered on time for client-facing and in-house development programmes
  • Accountable for control management, assay maintenance, data trending & analysis
  • Ensure all testing performed in compliance with the appropriate Quality, Safety and Environmental guidelines
  • Take primary responsibility for coordinating analytical testing for client and in-house development programmes and regulatory submissions where required
  • Performance management of Scientists & Laboratory Technicians; providing development opportunities, managing poor performance, resource planning, recruiting, motivating and building a strong team
  • Lead multi-disciplinary teams to ensure all analytical testing is performed to the appropriate quality standard and reported in a timely manner to facilitate process development
  • Assay and control material maintenance including data trending & analysis, to ensure continuity of testing
  • Ensure robust and compliant procedures in place to receive, issue, ship and dispose of analytical samples
  • Ensure analytics laboratories maintained to a high standard at all times, equipment is maintained and serviced, sufficient equipment & robust procedures for scheduling of analytical testing
  • Champion upcoming analytical technologies, and keep up to date with current literature and thinking.
  • Responsible for developing a resource strategy for the Process R&D Analytics team and identifying and communicating resource requirements for the department
  • Proactively identify project risk and issues to the relevant internal stakeholders and external collaborators at an early stage
  • Accountable for own and team’s performance in alignment with group objectives and deadlines
  • Work in accordance with the OXB quality management system
  • OXB PR&D Analytics representative at Client meetings, Client audits, Regulatory inspections and site visits by third parties
  • Interacts and influences with other key functions such as QA, Supply Chain, Analytical Services Group (ASG), Manufacturing Sciences & Technology (MSAT), Analytical Development (ADG) and QC at the manufacturing facility

To be successful in this role, you will have the following skills and experience:

  • PhD or equivalent degree in a relevant Science (e.g. Biological sciences, Biochemical Engineering, Virology, Molecular/Cellular biology) with extensive experience
  • Project Management qualification preferred
  • Excellent knowledge of the regulatory requirements for analytical work (e.g. ICH, product specifications, stability testing guidelines etc.)
  • Excellent technical understanding of biopharmaceutical process development and manufacturing
  • Has a broad and deep understanding of the full life cycle of the development of a product.
  • Broad knowledge of specific company processes for development and delivery of scientific process
  • Excellent knowledge and experience of cell culture, qPCR and ELISA.
  • Sophisticated relationship management skills to influence at high levels within Process R&D and OXB as a whole
  • Strong negotiating and analytical skills.
  • Strong Leadership experience
  • Strong oral communication and interpersonal skills
  • High level of experience using Microsoft Excel and/or Microsoft Project or other relevant software

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives.

No agencies please

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