Associate Specialist, Engineering
Merck
Durham, North Carolina, United States
- Lead and successfully execute multiple shakedown runs for pre-culture stage of drug substance biomanufacturing
- Work alongside Quality Assurance, Operations, and Automation teams to ensure PPQ readiness
- Author batch record procedures for cell pre-culture, exceeding 200 pages
- Train over a dozen Operation technicians on manufacturing processes and equipment
- Redline and edit process batch records, SOPs, and forms to align with cGMP
- Provide upstream processing technical support from cell inoculation to production bioreactors