Analytical Development Principal Research Associate

Vertex Pharmaceuticals•Boston, MA

2d•Onsite

About The Position

Design, develop, execute and analyze characterization and release assays for identity, purity, strength and potency of cell- based products. Multiple analytical platforms will be employed including RT-qPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry, Flow-cam, ddPCR, Alphalisa and cell- based functional/ potency assays. Execute test methods in support of pluripotent stem cell Process Development activities. Troubleshoot, optimize, and trend assay performance. Report on project progress, write analytical development protocols and reports, provide recommendations to management. Identify, qualify, and manage analytical reagents as per regulatory standards. Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools. Perform statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of test methods. Establish reference standard materials as required to support assay validation. Transfer assays to QC and provide SME support for assay qualification, author transfer/qualification protocols and reports. Maintain excellent written documentation (e.g. lab notebook and test forms).

Requirements

Master's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 2 years of experience in the job offered or in a Analytical Development Principal Research Associate-related occupation.
Alternatively, a Bachelor’s degree Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 6 years of experience in the job offered or in a Analytical Development Principal Research Associate-related occupation.
Demonstrable experience in developing analytical methods in compliance with ICH guidelines.
Demonstrable experience assisting with assay platforms: RT-qPCR, ELISA, Western blots, Flow cytometry or cell- based functional/ potency assays.
Demonstrable experience assisting with the culture of multiple mammalian cell types and combination drug product (Cells + device).
Demonstrable experience using literature to design proof of concept studies.
Demonstrable experience writing technical documents including development reports, qualification protocols and qualification reports.

Nice To Haves

Experience with multiple analytical platforms including RT-qPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry, Flow-cam, ddPCR, Alphalisa and cell- based functional/ potency assays.

Responsibilities

Design, develop, execute and analyze characterization and release assays for identity, purity, strength and potency of cell- based products.
Execute test methods in support of pluripotent stem cell Process Development activities.
Troubleshoot, optimize, and trend assay performance.
Report on project progress, write analytical development protocols and reports, provide recommendations to management.
Identify, qualify, and manage analytical reagents as per regulatory standards.
Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
Perform statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of test methods.
Establish reference standard materials as required to support assay validation.
Transfer assays to QC and provide SME support for assay qualification, author transfer/qualification protocols and reports.
Maintain excellent written documentation (e.g. lab notebook and test forms).