Sr. Specialist, Bioanalytics

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

Benefits offered by this job

Health coverage overview

Well-being programs

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

ModernaTX, Inc. in Cambridge, MA is seeking a Senior Specialist, Bioanalytics to lead hands-on development and validation of quantitative bioanalytical methods, including ELISA, MSD, bDNA, and qPCR, for nonclinical programs.

You will partner with CROs, drive method transfer and troubleshooting, and contribute to IND filings. Requires a master’s degree in biotechnology or related field with 3 years of relevant experience, or a bachelor’s with 5 years of progressive experience.

Qualifications

• Master’s degree with 3 years of experience or Bachelor’s with 5 years shown.
• Experience with ELISA, MSD, and qPCR for bioanalysis.
• Experience handling PK/toxicokinetic endpoints in non-clinical programs.

Responsibilities

• Analyze data from CROs for ligand binding assays and quantify proteins.
• Develop and transfer bioanalytical methods and troubleshoot assays.
• Collaborate with cross functional teams for IND support.
• Review study designs and generate SOPs and reports.

Skills

Bioanalytical Assays

Bioanalytical Method Qualification

Bioanalytical method development

Sample analysis troubleshooting

Quantifying protein analytes

Immunology/pharmacology knowledge

Education

Master’s degree in Biotechnology, Microbiology, or related field

Bachelor’s degree with 5+ years progressive experience

Tools

ELISA

MSD

bDNA

qPCR

Job description

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

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.

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.

• 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

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

• 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
• 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 investments to help you plan for the future
• Location-specific perks and extras

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.