Keros Therapeutics · 4 hours ago
Senior Scientist, Analytical Development
Lexington, MA (Hybrid)
Full-time
Hybrid
Mid, Senior Level
$152K/yr - $181K/yr
2+ years expKeros is focused on delivering clinical benefits through innovative products targeting TGF-β signaling. The Senior Scientist in Analytical Development will design and develop potency assays, ensuring compliance with regulatory guidelines and collaborating with cross-functional teams to support product characterization and stability testing.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Develops and optimizes cell-based functional and ligand-binding assays for potency determination of Keros protein therapeutics
Supports the method development, qualification, and validation of methods at CMO or CRO for GMP biotherapeutic manufacturing, including the review and approval of protocols and reports
Provides in-house analytical testing capabilities for development activities
Define potency strategy and method design based on clinically relevant mechanisms of action (MoA), targeted method performance, and transferability
Apply knowledge of regulatory guidelines (ICH, USP chapters) to ensure compliance in bioassay development and validation
Independently resolves complex technical challenges and implement innovative solutions
Serves as a technical resource and mentor, training colleagues across multiple technologies
Stays current with emerging technologies, industry trends, and regulatory expectations related to potency methods for biologics
Reviews, interprets, and communicates complex data clearly to functional leadership and cross-functional teams
Leads analytical technology transfer activities internally and externally, building and maintaining key vendor relationships
Develop project strategies within Analytical Development and across functions, guiding team members to successful execution
Author technical reports, regulatory filing sections, and scientific publications as appropriate
Ensures that all developed methods are compatible with quality requirements including regulations, policies, applicable guidelines, and procedures
Qualification
Required
Demonstrated expertise in the development, validation, and lifecycle management of cell-based potency assays, including experience with relevant techniques and technologies
Robust understanding of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays
Demonstrated ability to communicate complex data clearly and concisely, with excellent scientific writing skills, strong attention to detail, and a proven track record of effective cross-functional collaboration
PhD 2+, MS 7+, BS 10+ years related experience in the pharmaceutical field, preferably with mAbs and Fc-fusion proteins, and a degree in analytical science, bioanalytical science, or preclinical development
Preferred
Expertise in the generation and/or use of analytical cell lines with stable expression of targets of interests and/or reporter constructs is preferred
Experience with analytical techniques such as chromatography, capillary electrophoresis, is desired
Familiarity with regulatory guidelines for method qualification/validation and experience authoring regulatory sections for IND through BLA filings is 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
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