Engineer, Downstream Process Development & MSAT
Full Job Posting
The Technical Operations Department at Scholar Rock is seeking a scientifically curious and motivated engineer in the Downstream PD & MSAT group.
The successful candidate is expected to be proficient in all aspects of the purification process and be comfortable working with a multifunctional team.
Experience
in late-stage process development and support of external manufacturing is preferred.
The selected candidate will work alongside in-house scientists to advance existing projects through the development lifecycle and transfer to CMOs.
Proficiency in AKTA operation, TFF, VRF, JMP for data trending and presentation, and design of experiment skills are key traits that will ensure success in this role.
- 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
- Technical presentation to greater TechOps team
- Support process development experiments to develop, optimize, and characterize purification processes for antibodies.
- Detailed documentation of all experimental studies
- Educational background in Chemical Engineering, Biochemistry, Biotechnology, or related biological Sciences.
- Direct experience working with mAbs is preferred, and MSAT experience is highly desirable
- BS with 6+ years of experience
- MS with 4+ years of experience
- Ph.D. with 0-2 years of experience
About Scholar Rock
Clinical-stage biopharmaceutical company developing selective medicines for people with serious neuromuscular diseases.
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