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Scientist, Analytical Science and Technology

Morrisville, North Carolina, United States

Position Summary:

The Scientist, Analytical Science and Technology (ASAT) role is responsible for executing analytical strategies/testing to support late-stage product development, method lifecycle management, and technology transfer for biologics and cell/gene therapy products. The primary location for this role is Morrisville location; however, this role will require travel to the Winston Salem location for the meetings, troubleshooting methods, and method validation activities.

Responsibilities:

  • Perform laboratory bench work with focus on executing scientific experimentation for analytical method development, regent development, improvement and troubleshooting analytical methods.
  • Perform experiments as needed to generate data for validations and other projects
  • Perform data processing, evaluation and interpretation of experimental data, drawing conclusions based on the results. 
  • Perform analytical testing of finished products and development samples. 
  • Participate in analytical activities including method development, validation, and various analytical studies. 
  • Assist in maintaining and updating all required SOP’s, test methods, protocols and reports.
  • Present data at team and cross functional level on the current projects.
  • Maintain current knowledge in the field of expertise and develop subject matter expertise with analytical technology.
  • Perform overall lab support functions including routine maintenance of analytical instruments, ordering and maintaining inventory of sample, reagents and lab supplies. 
  • The primary location for this role is Morrisville location; however this role will require travel to the Winston Salem location for the meetings, troubleshooting methods, and method validation activities.

 Qualifications:

 

  • BS in Biochemistry or Biology science or relevant scientific field with a minimum of 5 years of relevant industry/academic experience in a laboratory environment.
  • Prior working experience with multi-color flow cytometry, ELISA assays, and cell culture-based assays
  • Experience in authoring test methods supporting Quality Control operations.
  • Prior experience with conducting method development, and /or method validation is required.
  • Experience in Gene and/or Cell therapy is desirable.
  • Experience of using JMP or similar statistical tools is a plus
  • Working knowledge and experience with good documentation practices in cGMP settings is a plus.
  • Knowledge of ICH Quality Guidelines related to analytical method development and validation is desirable.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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