Keros Therapeutics · 7 hours ago
Senior Manager, MSAT Drug Substance
Lexington, MA (Hybrid)
Full-time
Hybrid
Senior Level, Lead/Staff
$105K/yr - $126K/yr
8+ years expKeros is focused on delivering significant clinical benefits through innovative therapies targeting dysfunctional TGF-β signaling. The Senior Manager, MSAT Drug Substance will lead biologics drug substance production, oversee tech transfers, and ensure compliance with regulatory submissions while collaborating with external partners to drive successful manufacturing campaigns.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Collaborate cross-functionally with process development to deliver manufacturing processes that meet the speed, yield, and product quality requirements of the development programs
Provide key technical upstream and downstream leadership for development programs including technology transfer, process design, manufacturing support, and person-in-plant
Lead technology transfer activities, including process fit and facility design at external CDMO, ensuring gap analyses and risks assessments are performed technical mitigations are in place for early stage MFG (Phase 1 and Phase 2)
Review and approve technical documentation including protocols, master batch records, and reports related to engineering and GMP runs
Support continuous process improvement and scale up activities using data analysis to increase yield while maintaining quality attributes for manufacturing process lifecycle management
Collaborate cross-functionally to support clinical drug substance manufacturing processes, tech transfer, supply chain, quality compliance, change management and product life cycle management
Provide guidance and author content for CMC regulatory submissions and ensure technical compliance with regional regulatory requirements
Partner with product development, manufacturing, quality and regulatory, lead quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place
Support Process Development team by performing USP or DSP experiments as necessary
Cultivate excellent working relationship with CMC stakeholders to deliver successful manufacturing campaigns
Qualification
Required
BS with 10+ years or MS with 8+ years or PhD with 5+ years of experience in biologics process development (upstream and/or downstream); process scale-up; technology transfer; cGMP manufacturing support; and regulatory submissions for protein therapeutics
Experience working with CDMOs for facility fit and tech transfer
Experience with cell culture and/or purification and scale-up
Experience with technical support of commercial products in external cGMP manufacturing including investigations and change management
Understanding of regulatory requirements and experience with authoring and reviewing CMC documents for multiple regulatory submissions
Excellent collaboration skills and ability to work cross functionally to achieve objectives
Strong work ethic, motivation, and scientific curiosity
Preferred
Experience working in process development labs preferred but not required
Experience with process data analysis and trending and statistical analysis preferred
Company
Keros Therapeutics
Keros is a clinical-stage biopharmaceutical company focusing on the discovery, development, and commercialization of novel treatments.
51-200 employees
H1B Sponsorship
Keros Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (3)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$379.5MKey Investors
Pontifax
2024-01-03Post Ipo Equity· $140M
2020-11-13Post Ipo Equity· $149.5M
2020-04-07IPO
Leadership Team
Lorena Lerner
Chief Scientific Officer
Recent News
Keros Therapeutics, Inc.
2025-11-21
2025-11-20
Keros Therapeutics, Inc.
2025-11-19
Company data provided by crunchbase