Sr. Specialist, Bioanalytics

Moderna • Cambridge, MA

9d • $89,900 - $143,800 • Onsite

About The Position

ModernaTX, Inc. seeks a Senior Specialist, Bioanalytics for its Cambridge, Massachusetts location. This role involves utilizing laboratory skills to analyze data from external vendors (CROs) for ligand binding assays (ELISA, MSD) to quantify protein analytes in nonclinical species. The specialist will make recommendations, troubleshoot, and support Investigational New Drug (IND) filings. They will also engage with CROs to manage method transfer, validation, bioanalysis, and troubleshooting of nonclinical bioanalytical methods like Pharmacokinetics (PK) and Ligand Binding Assay (LBA). A key responsibility includes hands-on development of quantitative bioanalytical methods (ELISA, MSD, bDNA, qPCR, immunogenicity assays) and exploring new technologies. The role requires collaboration with Therapeutic Areas, non-clinical teams, and program/project management to drive non-clinical development. The specialist will review and approve study designs, requirements, and workflows, generate/review Statements of Work (SoW), and assist with Purchase Orders (PO). They will also provide cross-functional input on best practices to external CROs, stay updated on scientific regulations, and support regulated bioanalysis. The role maintains responsibility for multiple assay-related aspects for platform and development programs and involves providing summary presentations and detailed reports to 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.
• In the alternative, a Bachelor’s degree in the stated fields and five (5) years of progressive post-baccalaureate experience in the stated positions.
• 3 years of experience must include: Bioanalytical Assays, including Ligand Binding Assays and hybridization-based quantitative bioanalytical methods to measure analytes in biological samples.
• 3 years of experience must include: Bioanalytical Method Qualification, Method transfer, and Method Validation.
• 3 years of experience must include: Bioanalytical method development for evaluating PK/Toxicokinetic, safety, and efficacy endpoints for non-clinical and platform programs.
• 3 years of experience must include: Performing sample analysis, troubleshooting and bioanalytical reports for assay validation.
• 3 years of experience must include: Quantifying protein analytes in non-clinical species and matrices.
• 3 years of experience must include: Troubleshooting and refining assay conditions to improve accuracy and reliability using knowledge of immunology and pharmacology.

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.
• Make recommendations and troubleshoot to support Investigational New Drug (IND) filings.
• Engage with CROs and manage method transfer, method validation, bioanalysis, and troubleshooting of nonclinical bioanalytical methods such as Pharmacokinetics (PK) and Ligand Binding Assay (LBA).
• Responsible for hands-on development of quantitative bioanalytical methods, including ELISA, MSD, branched DNA (bDNA), and quantitative Polymerase Chain Reaction (qPCR), and immunogenicity assays as needed.
• Explore new technologies to enhance sensitivity and dynamic range, among other parameters.
• Work with Therapeutic Areas, non-clinical teams and program/project management functions to drive non-clinical development of therapeutic candidates.
• Review and approve study designs, requirements, and overall workflows, generating and reviewing Standard of Work (SoW), assisting with Purchase Orders (PO), and any follow-up, in order to enable study conduct.
• Collaborate and provide input cross-functionally on knowledge gained from prior experience 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.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• 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
• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• Savings and investments to help you plan for the future

What This Job Offers

• Job Type: Full-time
• Career Level: Senior