Job Id: P1304991BOSJB_1674056106 Apply Now

Summary:

Our client is seeking a motivated Associate Scientist to join our quickly growing Analytical Development Sample Testing Group. The primary responsibilities for this position focus on executing analytical procedures relevant to gene therapy and cell therapy platforms. This will include performing advanced bioassay methods such as ddPCR, qPCR, ELISA, and MSD-based methods. The successful candidate will perform and analyze experiments to support process development on multiple preclinical and clinical programs, and support transfer and qualification activities into the Sample Testing Group.

Responsibilities

• Execute analytical test methods to support routine process development and stability samples
• Transfer activities around quantitative assays measuring process residual impurities
• Compliance with GxP, keep good lab notebook and experiment records
• Routinely perform and participate in the execution of analytical methods required to support CMC
• Work collaboratively with Process Development to gather and analyze data to develop an understanding of product critical quality attributes to guide testing and process control strategies
• Support project leads, key internal and external stakeholders to meet project deadlines
• Participate in day-to-day lab operations, and routine maintenance of lab equipment

Minimum Qualifications

• BS/ MS in biological sciences with 5+/ 2+ years respectively of relevant work experience in industry
• Extensive experience with ddPCR, ELISA, MSD, or qPCR is required
• Excellent oral and written communication skills
• Team player, good interpersonal and organizational skills, attention to detail
• Knowledge of QC and GMP regulations is desirable
• Ability to work in a highly collaborative, cross-functional environment is a must

Preferred Qualifications

• Experience in working with cell and gene therapy products and viral vectors preferred
• Understanding of assay development and qualification per FDA or ICH guidelines
• Experience in tech transfer of methods to GMP labs
• Understanding or knowledge of statistical tools such as ddPCR, QuantaSoft, SoftmaxPro, JMP, and extensive knowledge of Microsoft Excel.

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