Manufacturing Associate II

Role Summary

Manufacturing Associates perform processing steps and manufacturing support activities in the Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations, delivering therapies to patients who need them. Downstream (Purification) work is conducted in a clean environment governed by current Good Manufacturing Practices (cGMP). The factories run 24/7 and teams work 12-hour shifts (days 6am–6pm) on a 2-2-3 calendar rotation.

Responsibilities

• Execute daily manufacturing activities, including operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Document and record all cGMP data and information (including deviations) for processing steps and equipment activities. Create and revise key documentation like batch records, SLRs, and equipment logbooks
• Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, Cell Counts, etc.)
• Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
• Be a team player and leader; always showing up to contribute your energy and focus
• Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members

Qualifications

• Bachelor’s Degree (STEM preferred) or BioWork Certificate or Associate’s Degree transferrable experience or High School Diploma (or equivalent) with at least 6 months of direct and/or military experience