In this role, you will lead the manufacture of a diverse range of iPSC-derived products, ensuring they meet the highest standards of quality and consistency. You will play an integral part in executing manufacturing requests to fulfil commercial forecasts, maintaining sufficient stock levels to meet customer demands.

Working closely with the Product & Process Development (PPD) and Quality Control (QC) teams, you will support the effective management of the product lifecycle, ensuring smooth transitions from development to production and maintaining product quality over time. Your efforts will help drive the consistent delivery of high-quality products to meet business and customer needs.

Your key responsibilities will include:

• Executing production runs for a range of ioCell type products. Maintaining the highest standards or laboratory techniques whilst doing so. Managing your own schedule to balance the delivery of multiple cell types at once to continue to meet our commercial stock goals.
• Working with Product & Process Development teams to optimise the critical aspects of production protocols for new cell types, including scale-up of culture conditions, cryopreservation, thawing & QC. Lead the transfer of new SOPs into the team as the production group representative.
• Driving validation of new cell culture systems and equipment to support the continued expansion of our manufacturing output.
• Designing and executing experiments to deliver data on manufacturing consistency to support our product portfolio. Presenting this data to the team lead in order to make informed decisions around production process improvements.
• Supporting junior members of the team by providing intellectual and practical support.
• Promoting a proactive, continual improvement culture and systems to maintain high standards of service and good practice. Proactively identify opportunities to develop better ways of operating.
• Maintaining a clean and organised laboratory space, supporting cleaning and maintenance of the lab space where required.
• Compiling data from experimental work for review by the wider team. Presenting data to other team members in a variety of forums.
• Collaborating with team members and other departments to achieve project goals. Be proactive in your communication with others to support the most effective team dynamic focussed on common goals.

You…

• Hold a minimum Bachelor's degree qualification (or equivalent experience) in a relevant field of Biological Science.
• Are a motivated scientist demonstrating the highest scientific rigour, operational skill and work standards.
• Are process oriented and experienced in developing, optimising & implementing workflows, protocols, procedures and resources in a quality management environment.

With essential experience in…

• Demonstrable process development experience in a relevant industry.
• Proficiency in cell culture techniques at scale (Adherant and/or Suspension) in a relevant industrial role.
• Ability to develop, optimise & implement workflows, protocols, procedures and resources in a quality management environment.
• Experience working with Human induced pluripotent stem cell biology, characterisation and culture systems.
• Proven practical experience working with a range of iPSC derived cell types.
• Prior experience in process tech transfer.
• Excellent time management, organisation and communication skills.
• and possibly....
• 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.
• Experience of working in a regulated environment to GLP, GMP or similar.

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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