Senior Engineer, Manufacturing Science and Technology

Role Summary

Senior Engineer, Manufacturing Science and Technology based in Branchburg, NJ, will develop, scale up, implement, and execute manufacturing processes for Century’s cellular therapy programs. The role leads a team responsible for tech transfers, implements processes in the in-house GMP facility, and serves as a hands-on operator for the Phase I manufacturing campaign. It also drives ongoing process development, including scale-up and characterization, with extensive cross-functional collaboration.

Responsibilities

• Lead team responsible for tech transfers and implementation of iPSC derived cell process
• Develop, execute, analyze, and document process development and scale up experiments
• Identify and critically assess opportunities to improve cell therapy platform, such as manufacturing of cell products derived from induced pluripotent stem cells.
• Collaborate with internal and external team members
• Author and review technical documents (batch records, SOPs, reports, memos, etc.)
• Author and review CMC documents for regulatory filings (e.g. IND, BLA) in collaboration with other parts of organization
• Foster a collaborative and scientifically rigorous team culture.
• Represent Century at external conferences and/or meetings

Qualifications

• PhD in biological, technical, or cell engineering field with 4-6 years relevant experience, or BS/MS degree with 10+ years of relevant professional experience.
• Experience in design, optimization, scale-up, bioreactors, process control, and technology transfer of cell culture unit operations.
• Hands-on experience with analytical methods typically used in the manufacture and characterization of cell therapies or biological products
• Mammalian cell culture using closed system and automated/dynamic technologies
• Proficiency with statistical methods for data analysis (e.g., JMP, GraphPad Prism)