(Senior) Scientist, Analytical Science
5 days ago
**Company Background**
**Job Position**
(Senior) Scientist, Analytical Science
- Learn and master the cell therapy production processes and related analytical methods in both scientific knowledge and hands-on skills.
- Understand GMP regulation for manufacturing cell therapies and performing lot release assays and integrate them into approaches for consistent production of high-quality clinical trial materials for Tessa’s early and late phase clinical studies.
- Lead the deep scientific understanding of Tessa’s cell therapy products by designing and conducting in vitro characterization assays and establishing appropriate routine characterization and lot release assays for in-process and final products.
- Independently explore novel _in vitro_ studies to meaningfully assess immunological and mechanism-of-action functions of intermediates and final cell therapy products.
- Develop and qualify assays that will be transferred to the Quality Control group or used for characterization and/or regulatory filing.
- Identify critical quality attributes of the process intermediates, and final products, and perform analytic work for these attributes.
- Establish critical parameters and reagents as well as acceptable operational ranges of the cell therapy products and their in-process materials or critical process steps.
- Collaborate with the in vivo pharmacology and research groups towards a deeper understanding of underlining biology for products and correlation to clinical outcome.
- Perform training and technology transfer of assays across laboratories and sites for cell therapy assays and/or processes.
- Author reports documenting development efforts for product characterization and quality control of cell therapy products, intermediates, and critical reagents.
- Lead the effort in providing characterization product analysis for long-term monitoring of manufacturing processes after technology transfer, work with the production team for troubleshooting efforts, and advice in preventative actions to ensure long-term production success
- Mentoring junior scientists, if required.
**Requirements**:
- MSc/Ph.D. in Immunology or Life Sciences with at least 5-7 years of experience working in developing therapeutic biological drugs; experience with cell therapy and CMC knowledge is highly preferred. Applicants with BSc and extensive experience in developing and qualifying analytical lot release assays will also be considered.
- Strong understanding of the immune system and dysregulation and excellent hands-on skills in various immune research techniques (Flow, ELISA, and ELISPOT assays), **AND/OR**:
- Technical and hands-on experience in developing genetic and genomic assays for product release and characterization, i.e., RCR qPCR assays, Viral Copy Number assays using ddPCR, and experience with NGS sequencing methods and analysis.
- Knowledge and experience working with viral vectors and characterization.
- Strong analytical skills and good scientific writing and presentation skills.
- Good problem-solving and communication skills
- Highly self-motivated and a good team player
- Experience with statistical analysis using JMP, Prism, and setting up DOE studies will be highly preferred.
- Ability to work well under pressure and challenging timelines.
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