Assoc. Scientist, Engineering

Role Summary

We are seeking an eager and adaptable scientist to play a central role in pilot plant operations, supporting the scale-up and commercialization of our dynamic late-stage biologics pipeline within the expansive Biologics S&T portfolio.

As an Associate Scientist in Cell Culture Pilot Operations & Commercialization, you will be at the forefront of translating process development into manufacturing reality. You will gain hands-on experience operating pilot-scale bioreactors and supporting scale-up activities, while collaborating across functions to enable successful drug substance commercialization.

Your Work Will Directly Support

• Pilot-scale execution of cell culture processes
• Process scale-up and technology transfer
• Process characterization and validation
• Preparation for PPQs and regulatory filings

Key Responsibilities

• Pilot Operations (Primary Focus): Execute and support pilot-scale mammalian cell culture runs, including bioreactor setup, operation, monitoring, sampling, and troubleshooting. Ensure safe, compliant, and efficient execution of pilot activities.
• Scale-Up & Commercialization: Support scale-up of cell culture processes from lab to pilot and manufacturing scale, contributing to robust drug substance commercialization strategies.
• Technical Execution: Assist with process characterization studies, process validation (PPQ-enabling work), and regulatory filing support.
• Cross-Functional Collaboration: Partner with process development, manufacturing, quality, and regulatory teams to ensure seamless tech transfer and alignment.
• Problem Solving: Troubleshoot pilot equipment, bioreactor performance, and cell culture process deviations.
• Communication: Maintain clear documentation and communicate results effectively to stakeholders.
• Innovation & Continuous Improvement: Support initiatives to improve pilot efficiency, process robustness, and operational excellence.

Education & Experience

Minimum High School Diploma/GED with 5 years of relevant experience or Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with 0–2 years of relevant experience

What You Bring

• Hands-on or academic experience in mammalian cell culture
• Aseptic technique
• Bioreactor operations (bench or pilot scale preferred)
• Media/buffer preparation
• Strong interest in pilot plant operations and scale-up activities
• Strong attention to detail and data integrity
• Effective verbal and written communication skills
• A collaborative, ethical, and resilient mindset with a commitment to excellence