Principal Scientist, Team Lead - Upstream
- Experience Level
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. is essential
- Knowledge of bioprocessing scale-up, technology transfer, and/or process characterisation activities is essential
- 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.
No agencies please