Analytical Development Principal Research Associate

Vertex Inc.•Boston, MA

4d•$100,755 - $128,500•Onsite

About The Position

The Analytical Development Principal Research Associate will be responsible for designing, developing, executing, and analyzing characterization and release assays for cell-based products. This role involves employing multiple analytical platforms to assess identity, purity, strength, and potency. The associate will also execute test methods to support Process Development activities for pluripotent stem cells, troubleshoot and optimize assay performance, and report on project progress. Key responsibilities include identifying and qualifying analytical reagents, establishing assay design criteria using tools like Design of Experiments (DOE), performing statistical analysis for method validation, establishing reference standard materials, and transferring assays to Quality Control (QC) with Subject Matter Expert (SME) support. Maintaining excellent written documentation in lab notebooks and test forms is also crucial.

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 in 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.
Assisting with assay platforms: RT-qPCR, ELISA, Western blots, Flow cytometry or cell- based functional/ potency assays.
Assisting with the culture of multiple mammalian cell types and combination drug product (Cells + device).
Using literature to design proof of concept studies.
Writing technical documents including development reports, qualification protocols and qualification reports.

Responsibilities

Design, develop, execute and analyze characterization and release assays for identity, purity, strength and potency of cell- based products using multiple analytical platforms 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).