We are seeking a highly motivated and experienced analytical development Scientist to join our Chemistry, Manufacturing and Controls (CMC) organisation to lead and establish analytical development activities for our growing pipeline of exosome-based therapeutics.
We are looking for an individual with a desire to continue to work ‘hands-on’ in the laboratory whilst managing a small team of development scientists delivering all aspects of analytical development activities from the development and refinement of Analytical Technical Profiles (ATP’s) through to establishment of robust analytical methods in support of the analytical control strategy, qualification/validation, IND/IMPD/CTA filing and ultimately successful MAA/BLA filings.
This position is based at Evox Therapeutics facility at the Oxford Science Park, Oxford, UK and reports to the Vice President, Process Development.
- Lead and grow a small team of analytical development scientists as well as developing analytical methods ‘hands-on’.
- Support method lifecycle activities for analytical methods including assay transfer, design of validation studies, designing assay maintenance programs, and developing assay controls and trending programs.
- To work collaboratively with Research, Process Development and QC to develop and establish new techniques and recommend alternative approaches and potential solutions to analytical issues.
- Oversight of analytical method development at CRO’s and CMO’s.
- Provide analytical support to process development and pre-clinical manufacturing.
- PhD or BSc/MSc in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field.
Experience and Skills Requirements:
Training and experience will be appropriate to specific job requirements. The following categories will be assessed in each case:
- At least 5+ years direct laboratory experience in biologics and/or cell/viral product analytical development post PhD or 8+ years direct laboratory experience as above post BSc/MSc.
- Experience in developing, transferring, qualifying, validating methods in a regulated environment.
- Assay development experience in biological assays such as cell-based assays, potency methods (including bioassays), flow cytometry and ELISA.
- Sound understanding of regulatory agency guidance associated with analytical methods and assay qualification/validation.
- Ability to work in a high paced team environment, meet deadlines, and prioritise work from multiple projects.
- Ability to work well in a team.
- Effective communication skills.
- Good organisational skills.
- Supervisory experience.
Full-time 40 hours per week.