Scientist, Process Development (MSAT)
at Bit Bio
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
Lab Based Position
Your role in our team:
We are looking for an experienced member of the Manufacturing Science & Technology (MSAT) team to manage the process development, scale-up and optimisation of non-GMP processes 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 Process Development Scientist will work closely with the R&D, Clinical Translation, 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.
This role will be based at our site in Cambridge with flexibility for occasional home working.
Your key responsibilities will include:
Provide scientific leadership in the development of manufacturing processes for research grade iPSC-derived products. Including development of SOPs and
leading route cause analysis.
Execute complex experiments by overseeing their planning, execution and analysis. Including optimisation of key processes such as cryopreservation, establishment of QC criteria and running functional assays utilising scientific principles and statistical approaches such as design of experiments.
Maintain good documentation in electronic lab books.
Author high-quality technical documents, procedures and study reports.
Actively participate in presentations of lab data and scientific discussions in project and team meetings.
Coaching and mentoring of junior team members by providing intellectual and practical support and ensure group training needs are met.
Promote a culture of continuous improvement and develop systems to maintain high standards of service and good practice.
Have s Bachelor’s or Master’s degree in a relevant field of biological science with a PhD being desirable.
Have significant experience in a relevant industry or scientific organisation.
Are process oriented and experienced in developing, optimising & implementing workflows, protocols, procedures and resources in a quality management environment.
Are a motivated scientist demonstrating the highest scientific rigour, operational skill and work standards.
Have demonstrable experience in growing and leading a high-performing team of scientists.
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.
Knowledge of Design of Experiment and statistical analysis.
Team leadership and managing internal & external stakeholder relationships.
Experience in process tech transfer / transfer to GMP manufacture.
Experience of working in a regulated environment to GLP, GMP or similar.
Excellent time management, organisation and communication skills.
Financial management, calculating cost of goods, budget control and reporting.
Direct industrial experience working with biologics, gene and / or cell therapy process development & optimisation.
Cell phenotyping and functional end point analysis e.g. flow cytometry, qPCR, ICC, MEA analysis
Expertise in continuous improvement and its implementation (e.g. LEAN, 5S) and experience of working to a quality management system.
Experience in automation and bioreactor operation
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.
For information on how we will manage your data please see our Candidate Privacy Notice- https://www.bit.bio/candidate-privacy-notice