Director, Analytical Development

Director, Analytical Development

Lexington, MA (Hybrid)

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
• Provide and develop laboratory based analytical support to upstream and downstream process development to drive new and improved processes for DS production
• Provide leadership and mentorship to a team of scientists and analysts
• Support cross-functional team coordinating efforts of the Technical Operations, Quality, and Regulatory to advance programs
• Drive analytical support for regulatory submissions, including IND amendments, BLA/MAA filings, and responses to health authority questions
• Author Analytical CMC sections of IND filings, internal SOPs, experimental procedures, training and safety documents

Core Competencies (Required Skills)

• Experience with biologics analytical support in late-stage activities (Phase 3 and commercialization)
• Strong background in protein characterization, analytical method development, qualification/validation, and physicochemical characterization of fusion proteins and protein therapeutics
• Deep understanding of analytical methods and data interpretation to evaluate protein structure, post translational modifications, and characterization
• Experience supporting transitions from discovery through IND-enabling or early clinical development is strongly valued

Education Requirements and Qualifications

• MS with 10+ years or PhD with 7+ years in molecular/cellular/structural biology, biochemistry, or a related field
• Proficiency with biochemical and biophysical methods:
• CE (CSDS, CIEF and CGE DNA), qPCR, potency, MFI/HIAC, DSF, DLS, DSC, and LCMS/MS peptide mapping & subunit analysis
• Chromatography: IA, SEC, RP, HIC and IEX
• Glycosylation: monosaccharide, sialic acid characterization and N-linked Glycan analysis
• Spectroscopy: UV/Vis, luminescence
• Experience in biochemistry techniques such as protein expression, gel electrophoresis, protein quantification assays, ELISA, cell-based assays, and enzyme kinetics
• Understanding of molecular biology, recombinant protein expression and construct design for affinity purification methods; familiarity with standard expression hosts such as mammalian, is a plus
• Experience in purifying proteins through recombinant processes is a plus
• Excellent collaboration skills and ability to work cross functionally to achieve objectives
• Strong work ethic, motivation, and scientific curiosity

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.

Potential base pay range

$200,000 - $226,000 USD

Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.