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.