--- title: 'Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT) at Scholar Rock' canonical: 'https://feeny.ai/job/senior-engineer-ii-downstream-manufacturing-science-technology-msat-scholar-geqsvbrgdw82' type: 'job' last_seen: '2026-09-13' --- # Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT) at Scholar Rock - **Company:** Scholar Rock - **Location:** Cambridge, MA - **Compensation:** $125k–$160k - **Employment:** full-time - **Work type:** hybrid - **Posted:** 2026-08-31 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.lever.co/scholarrock/9c3df4f7-be61-458a-bf7e-56fcd98f5f48 ## Job description 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: Scholar Rock is seeking a Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT), to provide technical leadership for monoclonal antibody downstream manufacturing across a global external manufacturing network. This role serves as the downstream process SME supporting commercial manufacturing, technology transfer, PPQ/process validation, CPV, investigations, change control, regulatory support, and lifecycle management. The ideal candidate brings strong downstream biologics process expertise, significant GMP manufacturing experience, sound technical judgment, and the ability to partner effectively with CDMOs and internal Process Development, External Manufacturing, Quality, Regulatory, and Supply Chain teams.  This role is expected to influence cross-functional decision-making and serve as a trusted technical partner across downstream manufacturing activities. Position Responsibilities External Manufacturing Support: - - Provide downstream process oversight for late-stage clinical and commercial manufacturing at CDMOs, including campaign readiness, technical risk assessment, manufacturing planning, and execution support. - Serve as Person-in-Plant, as needed, for technology transfer, PPQ/process validation, and clinical/commercial manufacturing activities. - Provide timely technical support during critical manufacturing operations, including off-hours support when required. Process Monitoring & Lifecycle Management: - - Own and maintain process monitoring systems, manufacturing databases, lot histories, and CPV programs. - Analyze manufacturing performance through statistical trending and process monitoring tools to ensure processes remain in a state of control. - Support Annual Product Reviews (APRs), Product Quality Reviews (PQRs), and ongoing commercial lifecycle management activities including post-approval changes and continuous improvement initiatives. Technology Transfer & Validation: - - Collaborate with Process Development teams to ensure effective transfer of process knowledge into GMP manufacturing operations. - Support or lead process characterization, process performance qualification (PPQ), and process validation activities. - Contribute to generation and execution of validation protocols, validation reports, and associated technical documentation. Investigations, Change Control & Technical Leadership: - - Lead or support deviations, atypical results, process excursions, change controls, technical/risk assessments, CAPAs, and issue resolution for downstream manufacturing processes. - Present technical analyses, manufacturing trends, and process performance updates to cross-functional teams and leadership. Documentation & Regulatory Support: - - Review and author GMP manufacturing documentation, batch records, technical reports, , and regulatory submission content. - Support health authority responses, post-approval changes, inspections, and regulatory interactions as the downstream process SME. - Author technical assessments, risk assessments, manufacturing support documents, and process monitoring reports. Candidate Requirements - Bachelor’s, Master’s, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or a related discipline, with relevant MSAT, process engineering, GMP manufacturing, technology transfer, or biologics manufacturing experience. - BS with 10+ years, MS with 8+ years, or PhD with 2 - 5 years of relevant experience. - Experience supporting mAb downstream manufacturing processes in a GMP environment. - Strong knowledge of chromatography, viral filtration, TFF, and UF/DF operations. - Experience reviewing batch records, GMP manufacturing documentation, and technical reports. - Strong communication, organization, collaboration, and technical writing skills. ## Preferred Qualifications - Experience with commercial biologics manufacturing, CPV/APR/PQR, technology transfer, PPQ/process validation, deviation investigations, CAPA, change control, regulatory support, CDMO oversight, JMP/statistical trending, DoE, or process characterization. - Experience with AKTA systems or lab-scale downstream development is desirable but not required. - Travel: Approximately 25% travel to support technology transfer, process validation, commercial manufacturing, and external manufacturing partners. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. ## About Scholar Rock ## Company Overview - **One-liner**: Scholar Rock is a biopharmaceutical company discovering and developing selective therapies targeting growth factors for serious diseases with high unmet need. - **Entity Type**: Public (NASDAQ: SRRK) - **Headquarters**: Cambridge, Massachusetts, United States - **Founded**: 2012 - **Founders**: Not publicly available ## Core Business - **Primary industry**: Biotechnology / Biopharmaceuticals - **Target customers**: Patients suffering from neuromuscular disorders, cancer, fibrotic diseases, and hematologic conditions; healthcare providers and payers - **Mission**: “Turning scientific discoveries into a pipeline of investigational therapies aimed at diseases where growth factors play a central role.” ## Products & Services - **Apitegromab (SRK-015)**: A selective anti‑latent myostatin antibody in Phase 3 for spinal muscular atrophy (SMA). BLA resubmission and U.S. launch anticipated in 2026. - **SRK‑181**: A selective anti‑latent TGFβ1 antibody for locally advanced or metastatic solid tumors (immuno‑oncology). - **SRK‑373**: A context‑dependent anti‑latent TGFβ1 antibody for multiple fibrotic indications. - **SRK‑256**: A selective anti‑RGMc/HJV antibody for hematology indications. - **Proprietary Platform**: Broad technology for generating monoclonal antibodies that selectively target latent forms of growth factors (TGFβ superfamily). ## Market Standing - **Valuation/Market Cap**: $2.8 B (as of search date, 2026‑09‑06) - **Key Metric**: Annual revenue $0 (pre‑commercial); IPO in 2018 - **Notable Investors/Partners**: Not publicly available - **Growth Signals**: Headcount grew 27.4% YoY to 278 employees; workforce across 7 countries; 20,522 LinkedIn followers (+45.9% yearly); first company to show clinical proof‑of‑concept for a muscle‑targeted treatment in SMA. ## Competitive Advantages - First‑in‑class platform for selectively targeting latent growth factors (TGFβ superfamily), enabling high specificity and reduced off‑target effects. - Proven clinical proof‑of‑concept in SMA with apitegromab, a novel mechanism. - Broad pipeline spanning neuromuscular, oncology, fibrosis, and hematology, with multiple programs in Phase 2/3. ## Strategic Focus - Advance apitegromab toward regulatory submission and commercial launch in SMA. - Expand pipeline into cardiometabolic disorders and other growth‑factor‑driven diseases. - Leverage platform to address historically under‑addressed disease areas. ## Why Work Here - **Culture**: “Passion for science” and “every voice counts” – a collaborative, trust‑based environment focused on changing patients’ lives. - **Work Policy**: Hybrid (e.g., Senior Director, Business Analytics in Cambridge, MA) and on‑site roles available. - **Benefits**: Competitive health/dental/vision plans, life/AD&D insurance, short‑ and long‑term disability, paid parental leave, 401(k) match, financial wellness program, professional development, free parking/transit pass, onsite fitness center, weekly community lunches, peer‑to‑peer recognition. - **Engineering/Science Culture**: Emphasis on innovation, cross‑functional teamwork, and direct impact on serious diseases. ## Sources 1. [scholarrock.com – Company Overview](https://scholarrock.com/our-company/careers/) 2. [scholarrock.com – Investors & Media](https://scholarrock.com/investors-media/) 3. [scholarrock.com – Pipeline](https://scholarrock.com/our-pipeline/) 4. [jobs.lever.co/scholarrock – Open Positions](https://jobs.lever.co/scholarrock) 5. [linkedin.com/company/scholar-rock – Company Profile](https://linkedin.com/company/scholar-rock) ## Other roles at Scholar Rock - [Associate Director, Regulatory Strategy](https://feeny.ai/job/associate-director-regulatory-strategy-scholar-rock-cambridge-f1hv61jkjpqp) — Cambridge, MA - [Associate Director/Director, Medical Operations](https://feeny.ai/job/associate-director-director-medical-operations-scholar-rock-cambridge-2zkcpx861y8d) — Cambridge, MA - [Director, Global Quality Control](https://feeny.ai/job/director-global-quality-control-scholar-rock-cambridge-y0kcys765x92) — Cambridge, MA - [Sr. Director, Head of Clinical Quality Assurance](https://feeny.ai/job/sr-director-head-of-clinical-quality-assurance-scholar-rock-cambridge-5fm8rza72grm) — Cambridge, MA - [Senior Manager, Contracts](https://feeny.ai/job/senior-manager-contracts-scholar-rock-cambridge-97vvxfdw01z4) — Cambridge, MA - [Senior Accountant](https://feeny.ai/job/senior-accountant-scholar-rock-cambridge-sdm431e4jv6p) — Cambridge, MA - [Senior Manager, Veeva Regulatory & Data](https://feeny.ai/job/senior-manager-veeva-regulatory-data-scholar-rock-cambridge-ee5x01hnk5cr) — Cambridge, MA - [Senior Manager, Veeva Commercial & Data](https://feeny.ai/job/senior-manager-veeva-commercial-data-scholar-rock-cambridge-fnj9gskxvmye) — Cambridge, MA - [Senior Director, Chief Information Security Officer](https://feeny.ai/job/senior-director-chief-information-security-officer-scholar-rock-cambridge-7ge2fxy8xn9k) — Cambridge, MA - [Director, Research & Development Technology](https://feeny.ai/job/director-research-development-technology-scholar-rock-cambridge-kx634bmz0eyj) — Cambridge, MA