Job ID # 79731

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Bio Analytical Scientist on a contract basis. Please ONLY local candidates to Seattle WA. 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.

Work Location: Seattle WA

Pay: $54-56/hour W2

Required Skills:

• 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

• 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 novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists

• Serve as a subject matter expert responsible for developing robust analytical methods and expanding product and process understanding

• Independently develop and execute bioanalytical or molecular assays (e.g. chromatography, electrophoresis/CE assays)

• Identify issues, lead troubleshooting experiments, and determine solutions with minimal to no guidance

• Train users on method execution, data analyses, and proper use of instrumentation

• Lead qualification and transfer of analytical methods to external stakeholders

• Routinely present work at team, technical team, and department meetings

• Maintain meticulous laboratory notebooks

• Analyzing, interpreting, and presenting data to internal and external stakeholders (Power Point Presentations)

• Author, review and approve technical documents, including methods, protocols, reports, and SOPs

• Deliver lifecycle-managed analytical methods for multiple programs with an understanding of ICH/FDA/EMEA best practices and current thinking

• Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.

• BS, MS or PhD in Molecular Biology, Analytical Biochemistry, Immunology, Microbiology, Cell Biology, or related field

• Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis/CE, etc.

• Experience with writing technical and regulatory documents for interdepartmental use and external vendors (e.g., CMO’s)

• Knowledge of immunology and T cell biology as applied to the cell therapy field preferred

• Knowledge or experience with vector and gene editing analytics (AAV, CRISPR, etc) preferred

• Experience with molecular techniques (e.g., qPCR, RT-qPCR, and/or ddPCR) preferred

• Experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, Excel, Prism Graphpad) preferred

• Familiarity with statistical analysis and design on experiments (DoE) using JMP software preferred