bit.bio

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

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 development and execution of bioanalytical assays associated with the process development, scale-up and optimisation of our research and clinical grade cell products. You will work at the interface of R&D, providing technical and scientific expertise whilst devising robust bioanalytical assays which will enable the translation of products from proof of principle to sterile manufacture. The Assay 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 mainly at Cambridge, however it may require some work at our London facility and a willingness to travel within the group will be required.

Your key responsibilities will include:

Lead bioanalytical assay development & execution for process optimisation, engineering runs & GMP production.
Independently design, develop, troubleshoot, qualify and implement various bioanalytical assays for opti-ox products throughout the development lifecycle (process optimisation, tech transfer, engineering runs, GMP production).
Execute in vitro & cell-based assays using ELISA, MSD (meso scale discovery), protein analysis, cell-based activity, proliferation and potency assays, qPCR, in vitro immunogenicity and cell0free DNA assays.
Evaluate functionality of various in vitro bioanalytical assays in different biological matrices (human & animal).
Interface with academic collaborator’s and CROs in the tech transfer of bioanalytical assays.
Perform statistical analysis of experimental data from in vitro, non-cell and cell-based bioanalytical studies.
Maintain equipment calibration records, usage logs as well as a clean and safe lab environment.
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 CMC/PD meetings.
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.
You…

For Senior Scientist - Either a PhD in Bioengineering, Cell Biology, Biochemistry or related field with proven follow-on experience in academia or industry or a BSc / MSc in a relevant area of Biological Sciences with significant follow up experience.
For Scientist - A degree in Bioengineering, Cell Biology, Biochemistry or related field with proven hands-on 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 demonstrated 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…

Direct hands-on industrial experience with PK & ADA assay development, optimisation, qualification, validation, troubleshooting and automation support is essential.
Familiarity of current regulatory guidance and industry best practice relating to cell & gene therapy.
Human induced pluripotent stem cell biology, characterisation and culture systems
Ability to interpret, summarise and present scientific results in a clear, concise & accurate manner.
Team leadership and managing internal & external stakeholder relationships.
Excellent time management, organisation and communication skills.
...and possibly....

Working knowledge of assay qualification & validation.
Understanding of the data package and reports required to advance processes into clinical manufacturing.
Experience with flow cytometry and other cell-based assays.
Expertise in continuous improvement and its implementation (e.g. LEAN, 5S) and experience of working to a quality management system.

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