Their manufacturing operations are based in Stevenage which are scaling up to keep pace with the increasing volume needed and other therapies entering the clinic. This would be a site-based role working Monday to Friday.
The Operations Lead will be responsible for the successful scale up of manufacturing operations as well as preparing the team for scale up in a new commercial facility. It will also require ensuring implementation of lean manufacturing improvements and collaboration with other departments such as Quality, Engineering, Training, MSAT, Operations and Supply Chain.
Key Responsibilities:
- Day-to-day management of a cell manufacturing operation across multiple shifts. The expected annual volumes of 2000+ batches in multiple manufacturing suites.
- Maintaining staff and equipment capacity to support clinical and commercial patient demand, as well as managing risk mitigation when required.
- Planning training and development for operational staff, providing feedback (and development plans) for all team members.
- Monitoring work productivity, reporting on operational trends, and recommend or implement changes to continually improve work productivity and processes.
- Prioritizing cell manufacturing lean and continuous improvement initiatives, and implementing new ones as needed.
Experience
- Experienced within a similar level position in a manufacturing operation in a GMP environment ideally pharmaceutical, biotechnology or medical device industry with over 5+ years management experience.
- A strong leader of teams and an inspiring people manager who can lead and motivate a high performing team.
- Understanding of and familiarity with regulatory guidance governing pharma/cell-based biopharmaceutical manufacture.
- Data-driven and have an ability to implement improvements after analysing key metrics.
- Project Management and Change Management experience in a large operational team.
- Experience with implementation of MES (or other) computerised systems within an operational environment.
- Strong leadership experience of 24/7 shift operations would be advantageous
- Degree qualified in a technical field and IOSH is ideal, Lean Manufacturing/Green Belt is essential
The Company: The company are a pioneering and ambitious Biopharmaceutical company who have developed next-generation, programmed T-cell therapies to treat hematological cancers and solid tumours. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.