🛠 Tech Stack

💼 About This Role

You'll lead the development, scale-up, and tech transfer of lentiviral vector processes from lab to GMP scale. You'll apply Quality by Design (QbD) principles and support transitions through multiple clinical stages. This role offers the chance to work on cutting-edge immunotherapy platforms.

🎯 What You'll Do

• Lead process development and tech transfer for lentiviral vector drug substance and drug product.
• Represent Process Sciences on CMC program teams, contributing to strategy and risk assessment.
• Operate, troubleshoot, and improve lab and production scale processes and equipment.
• Design and execute experiments for process characterization and performance qualification.

📋 Requirements

• BS/MS in chemical engineering, biochemistry, or related field with 5/3 years of experience.
• Expertise in TFF, NFF, and process analytical technologies.
• Experience with experimental design, planning, and complex data analysis.
• Proficiency in tech transfer, GMP operations, and batch record authoring.

✨ Nice to Have

• Working knowledge of lentiviral vector processes including bioreactors and Repligen TFF.
• Experience with fill-finish CDMOs and capital projects.
• Experience with Aseptic Process Simulations and Hazard Identification risk tools.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Application Review· 30 min
2. 2Phone Screen· 30 min
3. 3Technical Interview· 1 hour