Bioanalytical Scientist

Job Title : Bioanalytical Scientist

Location : Seattle, WA

Compensation : $50.00 - $56.00 / hr

Type : Contract, Potential for extension or conversion to permanent

Responsibilities

• 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.

Requirements

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

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.