Freeline Therapeutics (“Freeline”), is a biopharmaceutical company focused on the development of gene therapies for bleeding and other monogenic debilitating disorders, based in the United Kingdom.
Freeline was launched in December 2015 with an initial £25 million Series A financing from Syncona LLP continuing with series B financing this year. Freeline is based at the Stevenage BioScience Catalyst and the Cell and Gene Therapy Catapult GMP Manufacturing Centre, Stevenage. Freeline also owns the German laboratory facility Freeline Therapeutics GmbH.
The Company’s next-generation AAV gene therapy platform has been developed by Professor Amit Nathwani, Founder and Chief Scientific Officer of Freeline and Professor of Haematology at University College London. The platform is founded on the successful haemophilia B phase I/II trial conducted by his group with St. Jude Children’s Research Hospital. The results of the study, published in the New England Journal of Medicine, demonstrated that all ten of the treated haemophilia B patients showed safe, sustained expression of blood clotting Factor IX following a single treatment.
As part of building our team to drive our portfolio forwards we are seeking a Senior Scientist Quality Control. This person will report to the Director Quality Control and, in collaboration with the senior CMC scientific team and Quality Assurance, will be responsible for management of QC analytical strategies, growing and developing the internal freeline QC regulated laboratory skill base with a focus on quality and GMP compliance, plus assisting with selection and management of external contracted partner laboratories. The successful candidate will play a key operational role in securing successful delivery of the Freeline CMC development programmes, building internal QC capability, and ensuring compliant release testing of GMP batches at both CMOs and the Catapult MC.
The successful candidate will join a rapidly growing world-class multidisciplinary team and will have the rare opportunity to not only to engage in laboratory science but also influence the shape and direction of this exciting new biotechnology venture.
Working with the Director Quality Control, Quality Assurance team and the Freeline laboratory operations teams:
- Management of the Freeline Quality Control Laboratory (located alongside of Freeline’s GMP facilities in the Cell&Gene Therapy Catapult Manufacturing Centre Stevenage).
- Support and manage identified/allocated outsourced programmes of work, providing scientific scrutiny and interpretation, ensuring compliant testing outcomes
- Management of analytical methods transfer, development and validation at and between partner contract research organisations and insourcing to Freeline
- Develop and maintain systems for specification approval, CofA issuance, stability testing and analytical trending.
- Develop laboratory expertise in Freeline’s Quality Control laboratory best practice attainment of compliant systems, in preparation for GMP inspection and certification for QC testing
- Degree with experience in the Analytical Sciences relevant to Quality Control of Biotechnology/Biopharmaceuticals/Vaccines gained in the industrial field and of working within a Quality Management System
- Current awareness and demonstrable experience in Good Manufacturing Practice Quality control testing regulatory compliance (MHRA GMP Guidelines, Eudralex vol. 4, QC Annexes)
- Demonstrable knowledge of the documentation requirements for GMP Quality Control including maintenance of data integrity, computer systems validation, equipment procurement and qualification
- Working within controlled document systems, the faithful reporting of data, generation of certificates, protocols, SOPs and written reports
- Experience of working in pharmaceutical field with a regulated testing focus and of working in collaboration with Quality Assurance professionals, including supplier audits and in house auditing programs including environmental monitoring
- Significant experience in Physicochemical, Biochemical, and Biological assays in a variety of applications
- Detailed understanding of requirements of analytical methods validation and an awareness of all relevant guidance and regulations pertaining
- Experience of working across multi-disciplinary, multi-cultural teams and with external partners
- A working knowledge of Project Management, management of contracts.
- Higher degree in a relevant discipline
- A wide range of analytical techniques and expertise in analytical development
- Experience of analytical process science, and/or formulation science for viral gene therapy products
- Experience of early stage clinical development
- Professional qualifications with independent recognition by learned societies
- A good understanding of the biopharmaceutical development process and current awareness of developing trends in gene therapy regulatory requirements would be helpful.
To apply for this role email your CV and covering letter to firstname.lastname@example.org
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