Sr. Specialist, Bioanalytics

The Role

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

Heres What Youll 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.

Heres What Youll Bring to the Table

• Requires a Masters 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 Bachelors 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 $89900 to $143800. 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 $116700 to $143800. An individuals 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 (Job ID: R19584) or email resume and cover letter to with subject line: R19584.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat 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. Thats why our benefits and well-being resources are designed to support youat 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.