You will manage activities related to the development, validation and implementation of analytical methods for the testing, lot release and characterization of innovative gene-modified cell-based therapeutic products. More specifically, working with designated Contract Manufacturing Organisations (CMOs) and Contract Testing Organisations (CTOs) this individual will manage activities to provide analytical support to facilitate the progression of product pipeline programs.
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 analytical functions associated with the development, GMP production and testing of company products
· Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products
· Manage activities at CMOs and CTOs for the development, qualification and implementation of analytical methods, including the design, review and approval of protocols, test records/forms, final reports and Standard Operating Procedures (SOPs)
· Manage QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
· Establish and oversee/execute stability programs for raw materials, ancillary products, drug substances and drug products
· Draft and review SOPs, records/forms and protocols for in-house QC testing and overall analytical operations
· Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
· Assist in the preparation of CMC regulatory submissions
You will be a proven technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry. In order to be considered for this role, 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, validation and application of analytical methods for product development, characterisation and QC testing
· Experience of the characterisation and QC release testing of viral vector-based and/or cell-based products a plus
· Experience with the development, validation and application of analytical techniques in a QC environment, including FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays
· Experience of managing CMO/CTO relationships and projects
· Sound understanding and demonstrated application of statistical methods/tools
· In-depth knowledge of US and European Pharmacopeia methods and requirements
· In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements
· This position requires frequent on site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite
· A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
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.
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 ST41370 in all correspondence.
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