Bio Analytical Scientist
Listed on 2025-12-05
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Research/Development
Research Scientist, Data Scientist
Position Summary:
Cell Therapy Product and Analytical Development (P&AD) is seeking an enthusiastic, self-driven Scientist to join its Residual, Ancillary Materials and Protein Characterization analytical development team. The Scientist will lead development of analytical methods to characterize process-related impurities and assess impurity clearance in autologous and allogenic cell therapies. The Scientist will be responsible for developing impactful methods, including QC methods for lot release testing as well as characterization methods that support process development and comparability assessments.
These methods will be used to further our understanding of cell therapies, and support development of manufacturing processes, and/or QC release of the drug product. The successful candidate must have extensive hands-on experience in assay development and possess excellent communication skills in order to work on projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC.
Additionally, the Scientist will interface with external vendors (e.g., CMO's) for the successful management of any transferred analytical methods. The Scientist should be passionate about developing Client medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.
Education:
• BS, MS or PhD in Molecular Biology, Analytical Biochemistry, Immunology, Microbiology, Cell Biology, or related field. PhD with 0-3 years, or MS with 3+ years, or BS with 7+ years of relevant industry experience.
Basic Qualifications
• Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis/CE, etc.
• Experience working with Waters UPLC system and Empower software
• Methods: SEC-U/HPLC, SEC-MALS, IEX, RP-LC, Affinity, CE: PA800 (SCIEX) CE-SDS, CZE, cIEF
• Experience with proteins characterization preferred
• Strong problem-solving ability to troubleshoot complex technical and scientific problems.
• Experience with writing technical and regulatory documents for interdepartmental use and external vendors (e.g., CMO's).
• Strong attention to detail.
• Outstanding written and oral communication skills.
• Work effectively in a collaborative team setting.
• Ability to work in a rapidly changing environment with frequent changes in priorities.
Preferred Qualifications
- • Knowledge of immunology and T cell biology as applied to the cell therapy field
• Knowledge or experience with vector and gene editing analytics (AAV, CRISPR, etc)
• Experience with molecular techniques (e.g., qPCR, RT-qPCR, and/or ddPCR).
• Experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, Excel, Prism Graphpad).
• Familiarity with statistical analysis and design on experiments (DoE) using JMP software.
• Track record of successful transfer and management of analytical methods
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