Associate Director of Cell Therapy Operations - London
Jason Johal at CK Science is currently recruiting for an Associate Director of Cell Therapy Operations to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.
You will manage activities related to the development, manufacture and delivery of innovative gene-modified cell-based therapeutic products. Such activities will include the validation and execution of manufacturing processes at European Contract Manufacturing Organizations (CMOs) supporting product programs in clinical trials and subsequent commercialisation.
Based in London and 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 implementation and validation of cell isolation, cell culture and cell transduction processes and controls at company designated European CMOs
- Manage the GMP production and distribution of gene-modified cell-based products to support clinical trials and commercial supply
- Lead 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 gene-modified cell therapy products
- Co-ordinate production activities with the QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones
As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry. 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 the development, manufacture, distribution and delivery of cell and gene-based therapy products
In-depth technical experience with a proven track record of developing, integrating and implementing equipment and platforms for closed system: o Cell isolation/purification o Cell culture o Cell transduction o Cell washing/volume reduction o Formulation and final fill of cell-based products
Proven experience of the set-up, technology transfer and validation of manufacturing processes at CMOs
- In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
DOE, PAT and QBD experience a plus
This position requires frequent on site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite
- A minimum BS or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences
- 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 Associate Director of Cell Therapy Operations position, please contact Jason Johal on 01438 842963 or email email@example.com. 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 ST41878 in all correspondence.