Director, Analytical Development

Keros Therapeutics; Lexington (MA); On-site; USD 180,000 - 320,000; Full time

Job summary

Keros Therapeutics is seeking an expert in Analytical Science and Protein Characterization to join our team as Director of Analytical Development, leading the analytical strategy, method development and characterization for our protein pipeline.

The ideal candidate will have hands-on laboratory expertise in modern analytical chemistry, exceptional organizational skills, and a proven ability to translate complex data into actionable scientific decisions while building productive partnerships

Qualifications

• Expert in Analytical Science and Protein Characterization with hands-on lab experience.
• Proven ability to translate complex data into actionable scientific decisions.

Responsibilities

• Lead analytical development strategy for early to late-stage biologics programs, including Pre-Clinical, Phase I and Phase II/III
• Develop the strategic implementation of increasing levels of structural, physical, and advanced protein characterization in phase appropriate manner
• Serve as the subject‑matter expert in protein characterization and stability for phase‑appropriate development of the pipeline
• Partner with Manufacturing, Process Development, and Quality teams to define and implement phase‑appropriate analytical methods, specifications, and control strategies to support DS and DP
• Advise and oversee CDMOs' analytical method development, transfer, and validation
• Collaborate with CDMOs and CROs to develop and optimize a range of analytical assays for the release and characterization on a series of fusion protein and mAb biologics at each stage from preclinical to commercial launch
• Provide oversight of CDMOs and external testing laboratories, ensuring timelines, data quality, and compliance
• Ensure analytical methods and specifications are scientifically justified, phase appropriate, and compliant with applicable compendial standards and regulatory guidelines
• Support comparability, stability, and characterization strategies for process changes and scale‑up

Job description

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

Job Summary

Keros Therapeutics is seeking an expert in Analytical Science and Protein Characterization to join our team as Director of Analytical Development. The incumbent will lead the analytical strategy, method development, and characterization for our novel protein pipeline. The ideal candidate will have a deep understanding of protein characterization hands‑on experience in the laboratory, excellent organizational skills and attention to detail, a demonstrated ability for self‑motivated and independent project execution, and a strong desire to learn. This position requires deep expertise in modern analytical chemistry and a strong ability to translate complex data into actionable scientific decisions. The ideal candidate will combine technical depth with proven leadership experience, sound scientific judgment, and the ability to build productive partnerships across internal teams and external collaborators.

Primary Responsibilities

• Lead analytical development strategy for early to late-stage biologics programs, including Pre-Clinical, Phase I and Phase II/III
• Develop the strategic implementation of increasing levels of structural, physical, and advanced protein characterization in phase appropriate manner
• Serve as the subject‑matter expert in protein characterization and stability for phase‑appropriate development of the pipeline
• Partner with Manufacturing, Process Development, and Quality teams to define and implement phase‑appropriate analytical methods, specifications, and control strategies to support DS and DP
• Advise and oversee CDMOs' analytical method development, transfer, and validation
• Collaborate with CDMOs and CROs to develop and optimize a range of analytical assays for the release and characterization on a series of fusion protein and mAb biologics at each stage from preclinical to commercial launch
• Provide oversight of CDMOs and external testing laboratories, ensuring timelines, data quality, and compliance
• Ensure analytical methods and specifications are scientifically justified, phase appropriate, and compliant with applicable compendial standards and regulatory guidelines
• Support comparability, stability, and characterization strategies for process changes and scale‑up