💼 About This Role

You'll drive technology transfer and manufacturing support for cell and gene therapy programs. You'll own batch records, SOPs, and equipment specification while collaborating with CMOs. This role combines process development with clinical manufacturing in a fast-paced biotech environment.

🎯 What You'll Do

• Drive technology transfer of manufacturing processes to external CMOs
• Create batch records and SOPs for development and GMP manufacturing
• Specify and purchase equipment, interact with vendors
• Support clinical manufacturing with on-floor troubleshooting and investigations

📋 Requirements

• BS in Bioengineering, Chemical Engineering, or related discipline
• 7+ years in life sciences supporting process development or manufacturing
• Proficiency with investigations and creating protocols and reports
• Ability to travel up to 15% and be flexible in job responsibilities

✨ Nice to Have

• Experience with cell therapy and viral vector processes
• Understanding of QTPP, CQAs, process risk assessments
• Experience with comparability strategies/submissions

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Technical Interview· 1 hour
3. 3On-site Interview· half day