Job Description

**Roles and 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.

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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Pay ranges between $45-56/hr based on experience 

Job Tags

Contract work,

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