Location: Babraham Research Campus, Cambridge

Type: Full time, permanent / Start: Immediate

Salary: Competitive / Hours: 40 p/w

Lab Based Position

Your role in our team:

We are looking for an experienced Scientist/Senior Scientist with an excellent track record to lead our Process Development (PD) team. The main objectives of the role are to manage the process development, optimisation, scale-up and tech transfer to production of our research grade iPSC-derived cell types. You will work at the interface of R&D, providing technical and scientific expertise whilst devising robust manufacturing processes which will enable the translation of products from proof of principle to sterile manufacture. This role will work closely with the R&D, iPSC Core, Production, Quality, Logistics and Commercial teams to deliver a quality product to market. As such, there is a requirement to be diplomatic, collaborative, customer focused, change agile, comfortable in leading and adapting to changing priorities in a rapidly growing business.

Your key responsibilities will include:

• Leading, inspiring and growing a team of dedicated scientists to establish a state-of-the-art PD team to support bit.bio’s R&D and cell manufacturing capabilities.
• Operational and strategic responsibility for running of the PD team.
• Contributing to the development of company strategic programmes by driving innovation relating to human iPSC culture, automation and manufacture.
• Work in close collaboration with other department leaders (Research, Genetic Engineering, iPSC Core, Production and Product Management) to achieve scientific & product launch objectives.
• Engage with the academic and scientific community to promote and diversify the company’s process development activities.
• Provide scientific leadership in the development of manufacturing processes. Including facility fit assessments, leading route cause analysis and in the development of SOPs.
• Lead on the scale-up & tech transfer of lab scale processes to pilot scale, in-house production and/or GMP production facilities.
• Support the delivery of manufacturing development projects by overseeing their planning, execution and analysis of results.
• Present data to key stakeholders in a timely manner to support go/no-go decision points.
• Completion of reports and supporting documents.
• Coaching and mentoring of junior members of the team by providing intellectual and practical support and ensuring group training needs are met.
• Promote a proactive, continual improvement culture and systems to maintain high standards of service and good practice.
• Proactively identify and determine current and future resource requirements – both people and systems – lead in the recruitment and establishment of both in a rapidly growing organisation.

You…

• Have a Master’s degree or PhD in a relevant field of biological science (or equivalent experience).
• Have a strong background working in the stem cell field in a relevant industry or scientific organisation/institution.
• Have demonstrated experience in growing and leading a high-performing team of scientists.
• Are process oriented and experienced in developing, optimising & implementing workflows, protocols, procedures and resources in a quality management environment.
• Understanding and experience with statistical and modelling software and tools, such as DoE, multivariate analysis and statistical tests.
• Understanding of GMP and QbD considerations in a large-scale manufacturing environment.
• Are a motivated scientist demonstrating the highest scientific rigour, operational skills and work standards.
• Are a passionate team player with excellent communication skills.
• Resilient, self-motivated and able to work well under pressure.
• Are humble - sincere and secure - accepts own mistakes - prioritises team over personal goals.
• Are hungry - driven and proactive - goes above and beyond the call of duty to achieve company results.
• Are smart - astute and persuasive - uses emotional intelligence to lead and inspire colleagues.

With essential experience in…

• Human induced pluripotent stem cell biology, characterisation and culture systems.
• Product & process development / optimisation experience.
• Driving process improvement projects.
• Commercialisation of iPSC-derived cell types.
• Team leadership and project management involving multiple internal and external stakeholders.
• Working within a quality management environment.
• Developing operational infrastructure.

...and possibly....

• Have experience in cell culture automation and cell manufacture.
• Have knowledge of cGMP processes and regulations applicable to human iPSCs.
• Have worked in large cell bank organisations.
• Experience of working within the cell therapy field and handling of clinical grade cell lines.
• Have experience of quality risk management.