Dedicated to transforming the lives of patients with inherited diseases through innovative gene therapy.
What you'll be doing
- Managing activities at CMOs and CTOs for the development, and qualification of analytical methods for OTL programmes including the design, review and approval of associated protocols, test records/forms, final reports and Standard Operating Procedures (SOPs).
- Managing GMP activities at CMOs and CTOs for the validation and on-going perform of analytical methods for OTL programmes including review and approval of associated protocols, test records/forms, final reports and SOPs.
- Laboratory-based development and qualification of analytical methods for OTL programmes including the design, review and approval of associated protocols, test records/forms, final reports and Standard Operating Procedures (SOPs) as required.
- Preparation and review of analytical sections for OTL CMC regulatory submissions including review of CMC regulatory submissions as part of the wider OTL CMC team(s) and preparation and review of responses to regulatory agency questions.
- Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products as required.
- Active participation on the design and execution of stability programs for raw materials, ancillary products, drug substances and drug products. Review of stability programme data as required.
- Representing Analytical Sciences on CMC team(s) as required.
- Minimum of five years of experience in the biotechnology or pharma industry with a primary focus on hands-on development, validation and application of analytical methods for product development, characterization and GMP testing.
- Practical experience and knowledge of the development, qualification, validation and application of analytical techniques in a QC environment including, but not limited to, techniques such FACS, ddPCR, ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays.
- Practical experience of managing and maintaining CMO/CTO relationships and projects.
- In-depth knowledge of European and US 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.
- Excellent written and oral communication skills
- Excellent interpersonal skills
- Outstanding organizational skills
- A minimum Ph.D or equivalent experience in Biological Sciences, Bioengineering, Chemistry or an associated discipline
- Work from home opportunities
- Health insurance
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