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Senior Scientist
2 months ago
We are seeking a highly skilled and experienced Senior Scientist to lead our Analytical CMC team. As a key member of our team, you will be responsible for developing and implementing analytical techniques to support the testing of our immunotherapy products.
Key Responsibilities- Lead the development and qualification of analytical assays to support CMC activities.
- Develop and perform characterisation assays for our products, ensuring they meet scientific standards.
- Provide technical leadership on assay transfers to Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).
- Provide technical support to CMOs/CTLs for performance of analytical assays for batch release, in-process-assessment, characterisation, and stability testing.
- Author and review standard operating procedures, assay qualification/development/transfer/validation reports, and analytical methods to ensure adherence to good quality guidelines.
- Manage junior colleagues and provide training as necessary.
- Perform and manage laboratory work to meet department objectives.
- Author and review analytical sections of regulatory submissions.
- Contribute to the routine running of the laboratory and maintenance of equipment.
- Participate in team and scientific meetings, presenting data and conclusions as required.
- Ph.D. or equivalent experience in a life science discipline.
- Practical laboratory experience, ideally gained in a Biotechnology/Pharmaceutical setting.
- Good practical experience in development and qualification/validation of analytical techniques, including ELISA methodologies, dPCR, qPCR, Western blotting, AEX, RP-HPLC, and other relevant techniques.
- Practical knowledge of ICH Q2 and Q14 and assay tech transfer.
- Ability to write and record laboratory activities clearly and accurately.
- Ability to analyze and research complex issues and write factual reports.
- Knowledge of GMP and assay troubleshooting and root cause analysis.
- Understanding of principles of Design of Experiments and relevant software.
- Line management experience.
- Understanding of methods used in the analysis of peptides and GMP stability studies and ICH Q1 guidelines.