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ASAT Scientist

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

This Scientist position will be part of Analytical Science and Technology (ASAT) team within the CMC Development department. S/He/They will provide expertise in method transfer, qualification, documentation, and validation, and hands-on analytical testing support to the process development, MSAT and Analytical Development teams for product and process characterization testing.  May additionally include bridging studies, method and specification review/updates.

 

Key Responsibilities:

  • Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer
  • Author and/or review technical documents, including method SOP, study protocol and technical report
  • Be a key Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing
  • Provide SME assessment for deviation, CAPA and change control
  • Perform analytical testing, specifically flow cytometry, in support of product and process characterization for clinical product.
  • Perform data trending analysis
  • Participate in internal and external meeting

 

Knowledge and Skills:

  • Excellent technical writing skills are essential
  • Hands-on experience with flow cytometry and In-depth knowledge of molecular and/or cell biology is required
  • Experience in Gene and Cell therapy is desirable
  • Experience with NGS technology is a desirable
  • Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept.
  • Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
  • Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
  • Partners effectively with internal and external functions
  • Experience of using JMP or similar statistical tools is a plus

 

Education and Experience:

BS or above in Biology, Biochemistry, Analytical Chemistry and related fields.

Minimum 8 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

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