Director, Analytics, Process R&D
- 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.
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