Position Overview:

We are seeking an Sr. Specialist, QC Automation, to support the transition of GMP release and stability assays onto automated platforms for cell and gene therapy products.  The role will assist in the scripting and execution of technical protocols for transfer and validation of automated cell based functional assays. This role will also execute traditional cell-based laboratory experiments, when applicable. In depth understanding of cell culture techniques, analytical techniques, such as next gene sequencing (NGS), Flow cytometry, ddPCR, qPCR, and ELISA, and a demonstrated track record of laboratory automation and robotics experience is required.  The role will support the GMP-validation of assay-automation in a fast-paced Quality Control laboratory located in Cambridge, Massachusetts.

Primary Responsibilities:

• Contribute to setup of the liquid handlers including instrument purchasing, IQ/OQ/PQ, and operation SOPs.
• Execute complex GMP release and stability testing including cell based functional methods, flow cytometry methods, ddPCR, ELISA, and NGS methods.
• Maintain and operate multiple liquid handler systems for a variety of automation methods.
• Collaborate and communicate effectively with R&D Lab Automation Group as well as other organizations to establish automated workflows for analytical testing support.
• Investigate unexpected results and study outcomes while comparing manual versus liquid handler methods and troubleshooting alongside with Automation engineer.
• Independently develop, author, and execute protocols, reports, and other related documents for assay automation
• Support the implementation and execution of assay automation training programs for QC Analysts
• Draft and review technical documents for both traditional laboratory testing and automated testing.
• Maintain inventory for automation supplies and work with sample vendors, as needed.
• Assist in managing instrument scheduling for multiple liquid handler.
• General cleaning and upkeep of the laboratory for liquid handlers in support of avoiding cross-contaminations between assays.

Qualifications:

• Master’s degree with 10+ years of relevant experience or bachelor’s with 12+ years of experience
• 5-7 years relevant automation experience required.
• Broad working understanding of molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, flow cytometry, ELISA, and NGS.
• Experience with Tecan Fluent script writing or interpreting script is required.
• Additional experience with Hamilton Vantage is desirable.
• Experience with additional programming languages python and R is desirable.
• Ability to critically think though experimental challenges and troubleshoot.
• Team player with excellent oral and written communication skills.
• Independently motivated, detail-oriented, and excellent problem-solving abilities.
• Domestic and international travel may be required to external CTLs and other Beam sites.