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BioAgilytix

Global bioanalytical testing for drug development

Senior Analyst - Ada/PK

Regulatory & Quality (Life Sciences)Updated on Nov 13
Full-timeDurham, NC, USANo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in life sciences, chemistry, biochemistry, or a related scientific discipline is required; an equivalent combination of directly relevant education, training, and experience may be considered.
  • A minimum of three years of relevant scientific or laboratory experience is required.
  • Familiarity with some or all of the following immunoassay platforms is required: ELISA, MSD-ECL, Gyrolab, Alphalisa, Licor, and Luminex.
  • Experience preparing samples, performing scientific calculations, reviewing data, and maintaining controlled laboratory documentation is required.
  • Working knowledge of common laboratory techniques, routine instrumentation, and scientific documentation requirements is required.
  • Ability to troubleshoot routine technical issues and recognize when escalation is needed is required.
  • Strong attention to detail when reviewing data, preparing samples, completing calculations, and documenting work is required.
  • Ability to organize multiple priorities and work effectively under changing timelines is required.
  • Clear written and verbal communication skills, including the ability to present scientific information to laboratory, quality, and project stakeholders, are required.
  • Strong computer and interpersonal skills are required.
  • The role requires use of appropriate personal protective equipment, including safety glasses, lab coats, and gloves, and may involve biological materials, laboratory chemicals, hazardous waste, and other potential irritants.
  • The role requires frequent movement, periods of standing or remaining stationary, repetitive hand movements, bending, crouching, and lifting or moving laboratory equipment and supplies weighing up to 20 pounds.
  • Occasional evening, weekend, or holiday work may be needed based on study schedules and business requirements.

Responsibilities

  • Perform routine assays and related laboratory activities using approved methods and standard operating procedures with limited day-to-day oversight.
  • Prepare reagents, standards, controls, samples, and dilution schemes for assigned studies and laboratory activities.
  • Review raw data and laboratory records for completeness, accuracy, consistency, and compliance with documentation requirements.
  • Prepare routine data summaries, study updates, summary tables, and presentation materials for internal discussions and project meetings.
  • Identify and troubleshoot common assay, equipment, workflow, and documentation issues, escalating complex or unusual concerns when appropriate.
  • Support peer review of routine assay data, laboratory records, and related documentation.
  • Maintain laboratory readiness by monitoring materials, consumables, equipment status, and workspace organization.
  • Help onboard and train Analysts on routine laboratory techniques, documentation practices, and standard workflows.
  • Communicate study progress, technical risks, and scheduling constraints to supervisors, scientists, and project stakeholders.
  • Balance multiple assignments and adjust priorities to meet client-driven timelines.
  • Perform other responsibilities based on project and laboratory needs.

Desired Qualifications

  • An advanced degree in life sciences or a related scientific discipline is preferred.
  • Experience training or supporting less-experienced laboratory team members is preferred.
  • Experience working in a client-driven or regulated laboratory environment is preferred.

About the Company

BioAgilytix

Global bioanalytical testing for drug development

BioAgilytix is a global bioanalytical laboratory offering testing services for pharma, biotech, and agricultural biotech. It specializes in large-molecule studies and provides PK/PD, cell-based, and immunogenicity assays to measure drug behavior and safety. Its services help clients develop and validate therapies and ensure product safety, including customizable COVID-19 testing packages. Its goal is to support drug and agricultural product development from research to regulatory approval by delivering precise, validated data.

Company size
501-1,000
Company stage
Growth Equity (Venture Capital)
Total funding
$30.1M
Headquarters
Durham, NC
Founded
2008

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