Sr. Specialist, Bioanalytics

ModernaTX • Cambridge, MA

8d • 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 like ELISA and MSD, quantifying protein analytes in nonclinical species and matrices. The specialist will make recommendations, troubleshoot, and support Investigational New Drug (IND) filings. Key responsibilities include engaging with CROs, managing method transfer, validation, bioanalysis, and troubleshooting of nonclinical bioanalytical methods (PK and LBA). The role also entails hands-on development of quantitative bioanalytical methods (ELISA, MSD, bDNA, qPCR, immunogenicity assays), exploring new technologies, and collaborating with Therapeutic Areas, non-clinical teams, and program/project management to advance therapeutic candidate development. The specialist will review and approve study designs, requirements, and workflows, generate/review Statements of Work (SoW), and assist with Purchase Orders (PO). Cross-functional collaboration is expected to share knowledge on best practices for laboratory techniques, method development, and qualification with external CROs. Staying current with scientific regulations and supporting regulated bioanalysis at CROs is crucial. The role requires maintaining responsibility for multiple assay-related aspects for platform and development programs, and 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, employer will accept 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.
• 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.

Responsibilities

• Utilize laboratory skills to analyze data generated by external vendors (CROs) from ligand binding assays (ELISA, MSD) for quantifying protein analytes in 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 (PK and LBA).
• Perform 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
• Annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

What This Job Offers

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