Sr. Specialist, Bioanalytics

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

The Role

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

The Role

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

Here’s What You’ll Do

• Utilizing laboratory skills, analyze data generated by external vendors, such as Contract Research Organizations, (CROs), from ligand binding assays such as Enzyme linked Immunosorbent Assays (ELISA) and Meso Scale Discovery (MSD) for quantifying protein analytes in relevant nonclinical species, matrices, and 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, and 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.

Here’s What You’ll Bring To The Table

• Requires a 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; and
  • Troubleshooting and refining assay conditions to improve accuracy and reliability using knowledge of immunology and pharmacology.

The salary range for this role is $89,900 to $143,800. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular position, based on its primary location, is $116,700 to $143,800. An individual’s placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• 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

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, 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
• Savingsandinvestmentsto help you plan for the future
• Location-specific perks and extras

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.