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 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 Scientist will be part of our small team focused on setting up Freelines internal GMP manufacturing capability. The candidate will be responsible for supporting the technology transfer, process validation and the ongoing GMP manufacture required for delivering our clinical viral vector batches.
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.
We are looking for an organised, enthusiastic 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
- Be part of the GMP manufacturing operations team responsible for delivering GMP manufacturing batches for clinical studies.
- 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 support investigations, OOS, incidents and CAPAs as required.
- To be part of the team responsible for technology transfer of the process into GMP according to the approved protocols.
- To work closely with facility and other supporting teams 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 2 years of hands-on, practical experience in biological drug substance GMP manufacturing operations.
- A sound understanding of the required industry standards for GMP manufacturing of investigational medicinal products.
- Hands on experience in the upstream and/or downstream processing for viral vector manufacturing.
- Experience in one or more of the following areas would be beneficial:
- Facility operations
- Equipment qualification and validation.
- Technology transfer.
- Process validation.
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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