Senior Engineer I

Role Summary

Senior Engineer I responsible for advancing cell therapy manufacturing. Contributes to the development of phase-appropriate manufacturing processes for cutting-edge cell therapy products, leveraging in-house and external manufacturing capabilities to deliver high-quality therapies to clinical patients. Brings expert-level knowledge of CAR-T GMP manufacturing and strong understanding of manufacturing batch records across multiple sites in a Process Development/MSAT environment. Location: Rockville, MD; Redwood City, CA.

Responsibilities

• Plan, organize, and execute lab experiments to support process development and manufacturing activities (e.g., investigations, process improvements, operator training).
• Provide technical expertise for T-cell manufacturing process changes, comparability assessments, deviations, investigations, change control, and regulatory submissions.
• Maintain accurate documentation, including lab notebooks, SOPs, and technical reports.
• Ensure a clean, safe, and compliant laboratory environment; manage equipment and supplies.
• Conduct studies on process understanding (e.g., lot-to-lot variability, hold times, software upgrades).
• Support technology transfer by testing and validating manufacturing batch records prior to implementation.
• Collaborate with internal and external partners (e.g., Analytical Development, Protein Sciences) for testing and related studies.
• Meet with MSAT/Manufacturing team regularly to conduct manufacturability assessments of any changes to the manufacturing process.
• Manage purchase orders, vendor relationships, and material ordering for lab operations.
• Oversee weekly equipment checks, lab organization, and safety compliance as a Lab Safety Team representative.
• Contribute to development plans, process definition, and optimization strategies.
• Summarize and present data in team meetings; actively participate in technical discussions.
• Troubleshoot and resolve technical challenges independently and collaboratively.

Qualifications

• BS in Chemical, Biological, Biomedical or Biochemical Engineering with 10+ yrs of relevant experience, MS with 7+ yrs of relevant experience, or PhD with 3+ years of relevant experience.
• Strong engineering, scientific and operational background in implementation of bioprocess unit operations and aseptic cell culture.
• Strong understanding of process development, technical transfer, and GMP operations and documentation.
• Experience with T or B-cell cultures is a plus.
• MSAT/Manufacturing experience is a plus.

Additional Requirements

• Travel to CA Arcellx Site up to 20% for training in manufacturing support as needed.