Engineer, Downstream Process Development & MSAT

Summary of Position:
The Downstream PD & MSAT group seeks a scientifically curious engineer proficient in purification processes and comfortable working with a cross-functional team. Experience in late-stage process development and support of external manufacturing is preferred. Partner with in-house scientists to advance projects and transfer to CDMOs.

Key Skills:
- Proficiency in AKTA operation, TFF, VRF, JMP for data trending and presentation
- Design of experiment (DOE) skills

Position Responsibilities:
- Support external manufacturing of clinical and commercial assets
- Own and maintain process monitoring databases (CPV and lot history)
- Support manufacturing campaign readiness review process
- Drive batch production record review processes
- Author and drive Downstream change control implementation
- Work closely with CDMO to support tech transfer and manufacturing activities
- Deliver technical presentations to the broader TechOps team
- Support process development experiments to develop, optimize, and characterize antibody purification processes
- Provide detailed documentation of experimental studies

Candidate Requirements:
- Educational background in Chemical Engineering, Biochemistry, Biotechnology, or related biological sciences
- Direct experience working with monoclonal antibodies (mAbs) preferred; MSAT experience highly desirable
- BS with 6+ years of experience
- MS with 4+ years of experience
- Ph.D. with 0–2 years of experience