Senior Bioanalytics Specialist: ELISA, PK & Method Transfer

BioSpace; Cambridge (MA); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being programs

Family planning benefits

Generous paid time off

Equity/bonus potential

Job summary

ModernaTX, Inc. in Cambridge, MA, seeks a Senior Specialist, Bioanalytics to lead hands-on development of quantitative bioanalytic methods (ELISA, MSD, bDNA, qPCR) and to collaborate with CROs on method transfer, validation, and troubleshooting to support IND filings.

You will engage Therapeutic Areas and non-clinical teams, review study designs, generate SOPs and POs, and stay current with regulatory requirements, delivering robust data and insights to internal and external stakeholders.

Qualifications

• Master’s degree in Biotechnology, Microbiology, or related field with 3 years of relevant experience, or Bachelor’s with 5 years progressive experience.
• Experience with Bioanalytical Assays including Ligand Binding Assays and hybridization-based methods.
• Experience with Bioanalytical method development, PK/toxicokinetics endpoints, and assay troubleshooting.

Responsibilities

• Analyze data from external vendors (CROs) for ELISA/MSD; support IND filings.
• Lead method transfer, validation, bioanalysis, and troubleshooting of nonclinical assays.
• Develop quantitative bioanalytical methods (ELISA, MSD, bDNA, qPCR) and immunogenicity assays as needed.
• Collaborate across Therapeutic Areas and non-clinical teams to advance development programs.
• Review study designs, write SOPs, assist with POs, and enable study execution.
• Provide input on best practices and stay current with regulatory requirements.

Skills

Bioanalytics

ELISA

MSD

qPCR

Immunogenicity assays

Method transfer

Method validation

PK/Toxicokinetic

Education

Master’s degree in Biotechnology

Master’s degree in Microbiology

Tools

ELISA instruments

MSD analyzer

qPCR instrument

Job description

ModernaTX, Inc. in Cambridge, MA, seeks a Senior Specialist, Bioanalytics to lead hands-on development of quantitative bioanalytic methods (ELISA, MSD, bDNA, qPCR) and to collaborate with CROs on method transfer, validation, and troubleshooting to support IND filings.

You will engage Therapeutic Areas and non-clinical teams, review study designs, generate SOPs and POs, and stay current with regulatory requirements, delivering robust data and insights to internal and external stakeholders.