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Principal Scientist, Team Lead - Upstream

OXB-PRD-19-117b
Competitive
Permanent
35 / per week - Full-Time
Cowley ,
Oxford

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 Principal Scientist, Team Lead - Upstream to join the team.  The purpose of this role is to be responsible for coordinating daily activities to ensure PR&D timelines are met, whilst maintaining compliance with GLP/GMP & safety regulations.

Your responsibilities in this role would be:

  • Responsible for the line management of a team of USP scientists and/or laboratory technicians; including managing performance, motivating the team and carrying out recruitment activities.
    • Manage and prioritise the team’s workload, ensuring results are delivered on time and at a high quality.
    • Ensure all direct reports or persons involved in projects are fully trained and maintain a high standard of record keeping and documentation of experiments so that information is clearly captured, disseminated and reported.
  • Perform, develop and optimise upstream processes for the production of lentiviral vectors, working within the Process R&D group.
  • Involvement in activities ranging from vector manufacture, process optimization, technology transfer, and process validation activities associated with the manufacture of new gene therapy vectors.
  • Provide upstream expertise and contribute to process design and scale-up, to deliver new and improved bio-manufacturing processes based on Quality by Design (QbD) using DoE.
  • Lead the design and execution of experiments/process characterisation/investigations in accordance with correct methodologies, policies and procedures.
  • Responsible for designing and co-ordinating the execution of upstream activities for scale-up/scale-down of existing bioprocesses across multiple bioreactor scales and platforms.
  • Analyse and interpret experimental data and report to stakeholders within OXB and to external clients.
  • As a subject matter expert, contribute to and/or lead troubleshooting and technical investigations as required.
  • Write, revise, review and approve SOPs, technical reports, and risk assessments, where appropriate.
  • Responsible for ensuring the GLP (and where necessary GMP) compliance of the laboratory and equipment.
  • Maintain a safe working environment by ensuring appropriate H&S training, risk assessments and COSHH assessments are in place.
  • Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.
  • Contribute to cross departmental activities and provide expert advice and technical input where needed.

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

  • BSc, MSc or PhD (or equivalent) in a relevant Bioscience with an appropriate level of relevant experience.
  • Relevant laboratory experience in one or more of the following areas: Tissue Culture, Upstream Bioprocessing, Molecular Biology or Protein Chemistry.
  • Knowledge of bioprocessing scale-up, technology transfer, and/or process characterisation activities highly beneficial for the role.
  • Good understanding of lentiviral vectors (or other gene therapy vectors), and associated product quality attributes.
  • Advanced understanding of cell culture principles and bioprocesses.
  • An understanding of metabolite analysis in the context of mammalian cell culture and media development.
  • Demonstrated experience with suspension cell culture.
  • Experience with the operation of laboratory, pilot or production scale bioreactors.
  • Competency in data capture, reporting and management systems, such as, but not limited to: Microsoft Excel, JMP, Design Expert™, Graphpad Prism
  • Awareness of regulatory requirements e.g. GMP, GLP, GCP, ICH and/or Validation and Quality Management systems.
  • Ability to provide direction and supervision for junior team members and direct reports, to deliver project/group/departmental objectives within the required timeframe.
  • Maintain a high ethical standard and a commitment to producing high quality work.

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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