MSAT Manager
at Bit Bio (View all jobs)
Cambridge, UK
bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.

As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.

Location: Babraham Research Campus, Cambridge

Type: Full time, permanent / Start: Immediate

Salary: Competitive / Hours: 40 p/w

Office & Lab Based Position

Your role in our team:

We are looking for an experienced scientific leader with an excellent track record to lead our Manufacturing, Science & Technology (MSAT) team. The main objectives of the role are to manage the process development, optimisation, scale up and tech transfer of GMP manufacture for a wide range of 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. The MSAT Manager will work closely with R&D, iPSC Core, Clinical Translation, 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 MSAT team to support bit.bio's R&D and cell manufacturing capabilities
Operational and strategic responsibility for the running of the MSAT 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, Clinical Translation, iPSC Core, Production and Product Management) to meet scientific, new product launch and clinical 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 and 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 clinical/commercial filing documents
Coaching and mentoring of junior members of the team by providing intellectual and practical support and ensure 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 proven experience working in the stem field in a relevant industry or scientific organisation/institution
Have demonstrable 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
Are a motivated scientist demonstrating highest scientific rigour, operational skills and work standards
Understanding and experience of statistical modelling software and tools such as DoE, multivariate analysis, statistical tests (ANOVA, t-test)
Understanding of GMP and QbD considerations in a large scale manufacturing environment
Are a passionate team player with excellent communication skills
Resilient, self motivated and able to work well under pressure
With essential experience in…

Human pluripotent stem cell biology, characterisation, culture systems and QC
Product & process development & optimisation
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
More reasons to join us:

bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.

We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.

Creativity and open minds are encouraged for everyone to contribute to the success of the company.

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