ProKidney
Associate 2, MS&T
Winston-Salem, North Carolina, United States · Staff+
Work authorization requiredDetected 25 days ago
Product ManagementGMPCell CultureResearch
About the role
- Collect and summarize process data including cell count, viability, growth kinetics, yield, recovery, and in-process control results.
- Assist with deviation investigations, CAPAs, change controls, and batch record reviews.
- Escalate abnormal trends, procedural issues, or unexpected results to senior technical staff.
Responsibilities
- Execute standard MSAT experiments and process-support studies using approved procedures.
- Support cell therapy process steps including cell culture, expansion, harvest, wash/concentration, formulation, cryopreservation, and thaw assessment.
- Process Monitoring and Quality-System Support
- Support routine process monitoring and continued process verification activities.
- Maintain accurate GMP and technical documentation.
- Escalation and Cross-Functional Support
- Contribute data and documentation that support technical assessments, product-impact evaluations, and lifecycle-management activities.
- Support chain of identity, chain of custody, contamination control, aseptic processing, and data integrity requirements.
- The MSAT Research Associate II performs standard laboratory and manufacturing-support activities with increasing independence.
- The role supports routine process monitoring, technical data collection, experimental execution, and documentation for cell therapy manufacturing processes while developing broader understanding of process performance, product quality, and control requirements.
Requirements
- Experience in laboratory operations, cell culture, biologics manufacturing, process development, or technical operations.
- Working knowledge of standard laboratory and cell-processing techniques.
- Education/Training:
- Associate degree in Biology, Biochemistry, Bioengineering, Chemical Engineering, Biotechnology, or a related field with 4-6 years of relevant experience, OR a bachelor's degree in one of these fields with 2-4 years of relevant experience. A bachelor's degree is preferred.
- Knowledge:
- Basic understanding of GMP, GDP, aseptic technique, and data integrity expectations.
- Ability to perform routine calculations, data summaries, and documentation review.
- Contributes to a team culture focused on accuracy, compliance, and patient impact.
- 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.
Nice to have
- A bachelor's degree is preferred.
Skills
- Collaborates effectively within MSAT, Manufacturing, and Quality teams.
- Builds technical ownership of assigned tasks.
- Certifications/Licenses: n/a
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
Visa & Work Authorization
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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This listing is sourced directly from ProKidney's careers page and normalized into a canonical job model.