Scientist/senior Scientist, Process Development

2 days ago


Cambridge, United Kingdom TEC PARTNERS LIMITED Full time

My client, an award-winning spin-out from the University of Cambridge, with their breakthrough technology combining synthetic biology focusing on a scalable technology platform capable of producing consistent batches of mammalian cells. This potential willunlock a new generation of medicine and will allow the research and drug development sectors to work with cells that are affected by disease. Overall, my clients aim to is create a platform of new generation cell and tissue therapies.

Scientist/Senior Scientist, Process Development Role

My client are looking for an experienced member of the Manufacturing Science & Technology (MSAT) team to manager the process development, scale-up and development optimisation of non-GMP processes into GMP manufacture for a wide range of iPSC-derived celltypes. You will work at the interface of R&D, providing technical and scientific expertise whilst delivering robust manufacturing processes which will enable the translation of products from proof of principle to sterile manufacturer. The Process DevelopmentScientist will work closely with a large multidisciplinary team to deliver quality products to market. As such, you will be required to be diplomatic, collaborative, customer focused and comfortable leading and adapting to changing priorities in a rapidlygrowing business.

Scientist/Senior Scientist, Process Development Responsibilities
- Provide scientific leadership in the development of manufacturing processes both research and clinical grade iPSC-derived products
- Development of SOP's, tech transfer into GMP leading route cause analysis
- Execute complex experiments by overseeing planning and establishment of QC criteria as well as running functional assay utilising scientific principles
- Maintain good documentation in electronic lab books
- Author high-quality technical documents
- Participate in presentation of lab data and scientific discussions CMC/PD meetings
- Coaching and mentoring of junior members of the team

Scientist/Senior Scientist, Process Development Requirements
- For Senior Scientist - either PhD in a relevant principle of Biological Sciences with demonstrable follow-on experience in academia or industry or MSc in a in a relevant are of Biological Sciences with significant follow-on experience
- For Scientist - A degree in Biological Sciences / stem cell biology with proven hands-on experience in a relevant industry ort scientific organisation
- A process oriented and experienced in developing, optimising and implementing workflows, protocols and procedures
- Motivated scientist demonstrating the highest scientific rigour, operation and work standards
- Are smart, astute and persuasive with the use of emotional intelligence to lead and inspire colleagues

Scientist/Senior Scientist, Process Development Essentials
- Human induced pluripotent stem cell biology, characterisation and culture systems
- Cell phenotyping and functional end point analysis - flow cytometry, qPCR, ICC, MEA analysis
- Team leadership and managing internal & external stakeholder relationships
- Financial management, calculating cost of goods
- Direct industrial experience work with biologics, gene and or cell therapy process development
- Understanding of data package and reports to advance processes

This is an opportunity to join a well funded and reputable cell and gene therapy company are set to disrupt the market once their product has been finalised for the research and biotech sectors. As such, competitive salary options and development opportunitiesare on offer.



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