Freeline Therapeutics (“Freeline”), is a biopharmaceutical company focused on the development of gene therapies for bleeding and other debilitating disorders, based in Stevenage, greater London in the United Kingdom
The Company’s next-generation AAV gene therapy platform has been developed by Professor Amit Nathwani, Founder and Chief Scientific Officer of Freeline as well as Professor of Haematology at University College London, and it builds on the successful haemophilia B phase I/II trial conducted by him with St. Jude Children’s Research Hospital. The results of the study, published in the New England Journal of Medicine, demonstrated that all ten treated haemophilia B patients showed safe, sustained expression of blood clotting Factor IX from a single treatment. In addition to gene therapy for haemophilia B, the Freeline pipeline includes gene therapy candidates for several other debilitating diseases and to ensure the continued outstanding work of the Freeline research team we are expanding our laboratory facilities.
As part of building our team to drive our portfolio forwards we are seeking a Laboratory Operations and Quality Manager. This person will report to the VP Finance and will work closely with the Research and CMC teams and will be responsible for driving a number of critical operational tasks in support of the Research team, drive tasks related to compliance with Health and Safety, as well as coordinate the QMS training in close collaboration with the Director of QA. Tasks include the set up of our new laboratory facilities in Stevenage, supporting the move of the laboratory from our current location to Stevenage, ensure the continued laboratory compliance including risk assessments, take responsibility for GXP document management and set-up and monitoring of QMS training.
The successful candidates will join a rapidly growing world-class team and will have the opportunity to play a part in shaping the growth of this exciting new biotechnology Company.
- Coordinate the set-up of new laboratory; drive and deliver a number of workstreams including the move of the laboratory from the Royal Free Hospital to SBC Stevenage.
- Implement and manage Health and Safety and GXP document management, and risk assessments.
- Support the implementation of GXP Quality Management System, facilitating training, roll-out and monitoring of training compliance.
- Ensure smooth running of the laboratories; ensure facilities are fully operational, equipment maintained, laboratory supplies purchased and managed, any necessary operational systems are implemented. Responsible for ordering, installing and maintaining new and existing equipment in the laboratories.
- Co-ordinate applications for appropriate licences such as GMO.
- Co-ordinate and monitor Occupational Health provision.
- Oversee the monitoring, training and inspection of Safety practices and Laboratories.
- Significant experience as a laboratory manager.
- Experience of managing training of QMS.
- Understanding and experience of compliance and risk management in a pharma context.
- Experience of working in a GXP environment.
- Experience of laboratory move an advantage .
- Ability to take initiative and take on and drive new challenges.
- Personable and effective communicator.
Interested applicants should submit their applications to firstname.lastname@example.org or click on the apply button
The application should include a one page letter outlining what makes the applicant suitable for working in Freeline Therapeutics. This letter should be accompanied by a two page C.V.
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