Associate 2, MS&T in Winston-Salem, North Carolina at PROKIDNEY

Position Summary:

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. This role supports a GMP cell therapy manufacturing environment and requires work in laboratories, manufacturing areas, cleanrooms, or office settings. The role may involve occasional weekend, evening, or on-call support depending on manufacturing campaign needs, patient scheduling, and product lifecycle priorities.

Essential Duties & Responsibilities:

• Standard Technical Execution
• 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.
• Collect and summarize process data including cell count, viability, growth kinetics, yield, recovery, and in-process control results.
  
  
• Process Monitoring and Quality-System Support
  • Support routine process monitoring and continued process verification activities.
  • Assist with deviation investigations, CAPAs, change controls, and batch record reviews.
  • Maintain accurate GMP and technical documentation.
  • Support chain of identity, chain of custody, contamination control, aseptic processing, and data integrity requirements.
    
    
• Escalation and Cross-Functional Support
• Escalate abnormal trends, procedural issues, or unexpected results to senior technical staff.
• Contribute data and documentation that support technical assessments, product-impact evaluations, and lifecycle-management activities.

Qualifications:

• Education/Training:
  • BS degree in biology, cell biology, biochemistry, bioengineering, chemical engineering, biotechnology, or related field.
  • BS degree with 24 years of relevant experience, or MS degree with limited experience.
• Experience:
• Experience in laboratory operations, cell culture, biologics manufacturing, process development, or technical operations.
• Knowledge:
  • Working knowledge of standard laboratory and cell-processing techniques.
  • Basic understanding of GMP, GDP, aseptic technique, and data integrity expectations.
• Skills:
  • Ability to perform routine calculations, data summaries, and documentation review.
  • Collaborates effectively within MSAT, Manufacturing, and Quality teams.
  • Builds technical ownership of assigned tasks.
  • Contributes to a team culture focused on accuracy, compliance, and patient impact.
• Certifications/Licenses: n/a