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Data Reviewer / Senior Research Associate

KBI Biopharma
Durham, NC Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 5/20/2025

Position Summary :

Reviews data associated with testing of in-process and drug substance / drug product samples and development, transfer, qualification, and validation of analytical methods.

Position Responsibilities :

  • Reviews data and reports associated with development, transfers, qualification, and validation of analytical methods and testing of in-process and drug substance / drug product samples
  • Verifies that calculations and documented information are present, complete, and accurate
  • Verifies that all analyses are performed per methodology and are in compliance with GMP requirements, when applicable
  • Understands experiments and assays used to develop methods and / or test samples; maintains and updates knowledge of instrumentation
  • Responsible for developing a current understanding of cGMP and other regulatory requirements
  • Maintains professional expertise through familiarity with scientific literature
  • Able to react to change productively and handle other essential tasks as assigned

Minimum Requirements :

  • For Senior Research Associate : B.S. degree and 4 years of related experience.M.S. degree and 2 years of related experience.
  • For Associate Scientist : B.S. degree and 5 years of related experience.M.S. degree and 3 years of related experience.
  • Able to react to change productively and handle other essential tasks as assigned.
  • Adheres to all safety requirements.
  • Salary Range : $74,000 - $102,300

    Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

    About KBI :

    KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500 customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit .

    Salary : $74,000 - $102,300

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