Engineer, Downstream Process Development & MSAT

Posted 7 Days Ago
Be an Early Applicant
Cambridge, MA, USA
Hybrid
115K-140K Annually
Senior level
Healthtech • Information Technology • Biotech • Pharmaceutical
The Role
Supports downstream process development, manufacturing science and technology, external manufacturing, and tech transfer for monoclonal antibody products. Responsibilities include purification process development and characterization, CDMO collaboration, process monitoring database ownership, campaign readiness reviews, batch record review, change control implementation, technical presentations, and comprehensive experimental documentation.
Summary Generated by Built In
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

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees

Skills Required

  • Bachelor's degree in Chemical Engineering, Biochemistry, Biotechnology, or related biological sciences
  • Bachelor's degree with 6 or more years of experience
  • Master's degree with 4 or more years of experience
  • Ph.D. with 0 to 2 years of experience
  • Proficiency in AKTA operation
  • Experience with TFF and VRF
  • Proficiency with JMP for data trending and presentation
  • Design of experiments skills
  • Direct experience working with monoclonal antibodies
  • MSAT experience
  • Experience in late-stage process development and support of external manufacturing
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The Company
HQ: Cambridge, Massachusetts
187 Employees
Year Founded: 2012

What We Do

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. For additional information on our guidelines, please visit https://scholarrock.com/community-guidelines/ For more information on how Scholar Rock collects, uses, and shares personal information, please visit: https://scholarrock.com/privacy-policy

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