1.0 BACKGROUND FOR THE ROLE
Freeline is a biopharmaceutical company focused on the development and commercialisation of gene therapies for bleeding and other debilitating disorders based on a next-generation AAV gene therapy platform developed by Amit Nathwani, Professor of Haematology at UCL and CSO of Freeline Therapeutics. Freeline is fast progressing several programmes towards clinical investigation simultaneously with building a state of the art manufacturing platform for AAV, and is now establishing a clinical manufacturing facility to ensure we can rapidly translate our novel therapies into the clinic.
We are currently looking for a GMP Lead Scientist to join our growing GMP Manufacturing Operations team to deliver Freelines novel therapies into the clinic. This position provides an exciting opportunity to be play a key role in the team establishing a cutting-edge manufacturing facility which will utilise our proprietary CMC platform for supplying our novel therapies to patients.
2.0 CANDIDATE PROFILE/ROLE
The GMP Lead Scientist will be part of our small team focused on setting up Freeline’s internal clinical manufacturing capability. The candidate will be responsible for practical delivery of the technology transfer, process validation and the ongoing GMP manufacture required for delivering our viral vector to clinical studies, working closely with the GMP Operations Director and Director of Process Development.
The successful candidate will have hands-on experience of Biologics Drug Substance GMP manufacturing operations and will be familiar with the practices and procedures involved with GMP manufacturing. The successful candidate will also have demonstrated practical experience manufacturing viral vector in either a GMP or development setting.
We are looking for a self-motivated, focused and adaptable individual who is keen to join our exciting and innovative company to deliver our expanding product pipeline to the clinic.
This role will report to the GMP Operations Director.
3.0 MAJOR DUTIES AND RESPONSIBILITIES
- Responsible for practical delivery of GMP manufacturing batches.
- Become fully trained in all areas of the manufacturing process as required.
- Write and review SOPs, batch records, protocols, reports etc. to support GMP manufacture.
- Ability to identify issues as they occur and report accordingly with all relevant information.
- To lead investigations, OOS, incidents and CAPAs as required.
- To work closely with the GMP Operations Director to plan activities required for facility set-up, equipment qualification, technology transfer, process validation and ongoing GMP manufacture.
- To be the lead scientist responsible for practical delivery of the technology transfer working closely with the Process Development and Analytical Development teams
- To liaise confidently with facility teams and other groups to ensure requirements for manufacture are met.
- General duties involved in the maintenance of clean room production facilities to GMP standards.
- General duties involved in the preparation of equipment, materials and facilities ready for GMP manufacture.
- BSc degree in biological science.
- At least 3 years of hands-on, practical experience in biological drug substance GMP manufacturing operations including planning, documentation and execution.
- Experience of operating large scale bioreactors and/or chromatography and TFF equipment
- Practical experience in the manufacture of viral vectors in either a development or GMP setting would be a significant advantage
- A proficient understanding of the required industry standards for GMP manufacturing of investigational medicinal products.
- Experience in technology transfer of processes into GMP facilities
- Experience in one or more of the following areas would be beneficial:
- Equipment qualification and validation.
- Process validation.
- Team supervision.
6.0 REMUNERATION PACKAGE
- Competitive salary, dependent on experience
- Bonus and share options
In return, the successful candidate will enjoy being part of a dynamic, forward thinking team, with the ability shape the Manufacturing and Supply function for a fast-moving biotech, and play a key role in Freelines mission to develop and use innovative technology to treat debilitating diseases.
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