Director of Vector Operations (Gene Therapy) - London
Jason Johal is currently recruiting for a Director of Vector Operations to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.
You will be responsible for activities related to the development and cGMP production of lentiviral vectors at European contract manufacturing organizations (CMOs). Such activities will include the scale-up, validation and execution of manufacturing processes and controls to support the innovative cell and gene therapy product programs from Phase I clinical trials through to commercial.
Offered on a full time permanent basis, the position comes with a comprehensive compensation package tailored around you.
Your main responsibilities in this role will be to:
- Manage the GMP production, testing and fill finish of lentiviral vectors at CMO's
- Drive activities for the DoE, protocol generation, execution and reporting of studies to validate production processes and associated assay method controls to support BLA/MAA submissions for company products
- Provide on-site person-in-plant oversight during production campaigns and key development/validation activities
- Assist in the reporting, investigation and resolution of deviations encountered during GMP production activities
- Provide expert compilation, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports
- Provide expert review and approval of executed batch, records, test records and associated documentation for release of lentiviral vector lots and for plasmid lots used in their production.
The ideal candidate for this position will have demonstrated experience of the large-scale cGMP production of lentiviral vectors, including upstream cell culture, downstream processing, and fill finish operations. You will also be required to have the following qualifications, skills and experience:
- Extensive experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, downstream processing, and fill finish operations for biologics
- In depth knowledge of lentiviral vector construction and biology
In-depth experience of the large-scale cGMP production of lentiviral vectors, including: o Upstream cell culture, downstream processing, and fill finish operations o Process characterization and validation
Proven track record of managing lentiviral vector development, validation and production both in-house, and at CMO's/partners
- Demonstrated ability to build and lead technical teams in fast-paced operational environments
- In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements for biologics
- Knowledge of Quality Systems, QBD and PAT as they relate to GMP production operations, process optimization and process validation
- This position requires on site person-in-plant presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite
- Minimum BSc or equivalent in bioprocessing, chemical engineering, vector biology, or biological sciences
- Experience of managing CMO relationships and projects
- Working knowledge of US and European regulatory requirements
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Fluency in French, German or Italian a plus
If successful you will be working in partnership with the world's leading research centres to harness the life-giving potential of gene therapy and striving to make the company the leader in gene therapy for primary immune deficiencies and inherited metabolic disorders. If you are passionate about transforming the lives of patients with rare disorders this is the right place for you.
For more information or to apply for this Director of Vector Operations position, please contact Jason Johal on 01438 723500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST41372 in all correspondence.