Sr. Specialist, Bioanalytics

ModernaTX, Inc. seeks a Senior Specialist, Bioanalytics for its Cambridge, Massachusetts location.

Responsibilities

Utilize laboratory skills to analyze data generated by external vendors (CROs) from ligand binding assays such as ELISA and MSD for quantifying protein analytes in relevant nonclinical species and matrices, and make recommendations and troubleshoot to support IND filings; Engage with CROs and manage method transfer, method validation, bioanalysis, and troubleshooting of nonclinical bioanalytical methods such as PK and LBA; Responsible for hands-on development of quantitative bioanalytical methods, including ELISA, MSD, bDNA, and qPCR, and immunogenicity assays as needed, and explore new technologies; Work with Therapeutic Areas, non-clinical teams and program/project management functions to drive non-clinical development; Review and approve study designs, requirements, and workflows, generating and reviewing SoW, assisting with POs; Collaborate cross-functionally on best practices for laboratory techniques, method development, and Qualification to external CROs; Remain up to date and proficient with current and changing scientific regulations and support regulated bioanalysis at CROs; Maintain responsibility for multiple assay-related aspects for platform and development programs; Provide summary presentations and detailed reports to internal and external stakeholders.

Requirements

Master’s degree in Biotechnology, Microbiology, or related field and three (3) years of experience in the offered position or as a Research Associate or related position; or Bachelor’s degree in the stated fields and five (5) years of progressive post-baccalaureate experience in the stated positions; Experience must include: Bioanalytical Assays, including Ligand Binding Assays and hybridization-based quantitative bioanalytical methods to measure analytes in biological samples; Bioanalytical Method Qualification, Method transfer, and Method Validation; Bioanalytical method development for evaluating PK/Toxicokinetic, safety, and efficacy endpoints for non-clinical and platform programs; Performing sample analysis, troubleshooting and bioanalytical reports for assay validation; Quantifying protein analytes in non-clinical species and matrices; Troubleshooting and refining assay conditions to improve accuracy and reliability using knowledge of immunology and pharmacology.

Benefits

Best-in-class healthcare coverage, plus voluntary benefit programs; A holistic approach to well-being, with access to fitness, mindfulness, and mental health support; Family planning benefits, including fertility, adoption, and surrogacy support; Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown; Savings and investment opportunities to help you plan for the future; Location-specific perks and extras; Eligible for an annual discretionary bonus, other incentive compensation, or equity award.