Method Validation Jobs in Massachusetts (NOW HIRING)

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.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R19584) or email resume and cover letter to careers@modernatx.com with subject line: R19584.

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.

#dni

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.