Manufacturing Associate IV

Role Summary

Manufacturing Associate IV performing processing steps and manufacturing support activities in the Drug Substance facility in Research Triangle Park (RTP). Works as part of biomanufacturing teams organized by process steps, operating in a clean environment governed by cGMP to deliver therapies to patients.

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 such as batch records, SLRs, and equipment logbooks
• Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, Cell Counts, etc.)
• Maintain a clean and safe work environment, with a focus on audit readiness of process areas
• Be a team player and leader; contribute energy and focus
• Actively participate and lead in training and development initiatives for personal growth and for team members

Qualifications

• Required: Bachelor’s Degree (STEM preferred) and at least 2 years of directly transferable experience OR
• Required: BioWork Certificate or Associate’s Degree + at least 2.5 years of directly transferable experience OR
• Required: High School Diploma (or equivalent) plus at least 3 years of direct and/or military experience