Jobless Developer
Scholar Rock logo
Scholar Rock

Posted 24 days ago

Open

Engineer, Downstream Process Development & MSAT

Cambridge, MAHybridFull-time

AI Summary

Engineer in the Downstream Process Development & MSAT group at Scholar Rock, responsible for supporting external manufacturing, maintaining process monitoring databases, driving batch production record reviews, authoring change control implementations, and supporting process development experiments for antibody purification.

About this role

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:

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.

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
  • 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

    • Candidate Requirements

  • 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

    • Skills

    AKTA OperationBatch Production Record ReviewChange Control ImplementationCPVData TrendingDesign Of ExperimentsJMPLot HistoryMABsMonoclonal AntibodiesMSATProcess Monitoring DatabasesPurification ProcessesTech TransferTFFVRF

    Explore related jobs

    More jobs at Scholar Rock

    Browse these categories

    Jobs in United States

    Market data for this role

    All reports →