Director, Analytical Development
Keros Therapeutics
August 14, 2026
Remote friendly (Lexington, MA)
United States
Operations
Director of Analytical Development — Analytical Science & Protein Characterization
Primary Responsibilities
- Lead analytical development strategy for early to late-stage biologics programs (Pre-Clinical, Phase I, Phase II/III).
- Implement phase-appropriate structural, physical, and advanced protein characterization.
- Serve as subject-matter expert in protein characterization and stability.
- Partner with Manufacturing, Process Development, and Quality to define/implement phase-appropriate analytical methods, specifications, and control strategies for DS and DP.
- Advise/oversee CDMOs for analytical method development, transfer, and validation.
- Collaborate with CDMOs/CROs to develop/optimize assays for release and characterization of fusion proteins and mAbs from preclinical through commercial launch.
- Oversee timelines, data quality, and compliance for CDMOs/external labs.
- Ensure methods/specifications are scientifically justified, phase-appropriate, and compliant with compendial/regulatory standards.
- Support comparability, stability, and characterization for process changes/scale-up.
- Provide laboratory analytical support to upstream/downstream process development for DS.
- Lead/mentor a team; coordinate across Technical Operations, Quality, and Regulatory.
- Drive analytical support for IND/BLA/MAA submissions and health authority responses; author Analytical CMC sections and related SOPs/procedures.
Required Skills/Competencies
- Late-stage biologics analytical support (Phase 3 and commercialization).
- Protein characterization, analytical method development, and qualification/validation for fusion proteins/protein therapeutics.
- Data interpretation for protein structure and post-translational modifications.
- Experience from discovery through IND-enabling/early clinical development (strongly valued).
Education/Qualifications
- MS (10+ years) or PhD (7+ years) in molecular/cellular/structural biology, biochemistry, or related field.
- Proficiency in CE/CIEF/CGE, qPCR, potency, MFI/HIAC, DSF, DLS, DSC, LCMS/MS peptide mapping; chromatography (IA, SEC, RP, HIC, IEX); glycosylation (monosaccharide/sialic acid/N-linked glycan); spectroscopy (UV/Vis, luminescence); protein expression, electrophoresis, quantification, ELISA, cell-based assays, enzyme kinetics; recombinant expression/construct design (mammalian hosts a plus); recombinant protein purification a plus.
Potential Base Pay Range
- $200,000—$226,000 USD
Primary Responsibilities
- Lead analytical development strategy for early to late-stage biologics programs (Pre-Clinical, Phase I, Phase II/III).
- Implement phase-appropriate structural, physical, and advanced protein characterization.
- Serve as subject-matter expert in protein characterization and stability.
- Partner with Manufacturing, Process Development, and Quality to define/implement phase-appropriate analytical methods, specifications, and control strategies for DS and DP.
- Advise/oversee CDMOs for analytical method development, transfer, and validation.
- Collaborate with CDMOs/CROs to develop/optimize assays for release and characterization of fusion proteins and mAbs from preclinical through commercial launch.
- Oversee timelines, data quality, and compliance for CDMOs/external labs.
- Ensure methods/specifications are scientifically justified, phase-appropriate, and compliant with compendial/regulatory standards.
- Support comparability, stability, and characterization for process changes/scale-up.
- Provide laboratory analytical support to upstream/downstream process development for DS.
- Lead/mentor a team; coordinate across Technical Operations, Quality, and Regulatory.
- Drive analytical support for IND/BLA/MAA submissions and health authority responses; author Analytical CMC sections and related SOPs/procedures.
Required Skills/Competencies
- Late-stage biologics analytical support (Phase 3 and commercialization).
- Protein characterization, analytical method development, and qualification/validation for fusion proteins/protein therapeutics.
- Data interpretation for protein structure and post-translational modifications.
- Experience from discovery through IND-enabling/early clinical development (strongly valued).
Education/Qualifications
- MS (10+ years) or PhD (7+ years) in molecular/cellular/structural biology, biochemistry, or related field.
- Proficiency in CE/CIEF/CGE, qPCR, potency, MFI/HIAC, DSF, DLS, DSC, LCMS/MS peptide mapping; chromatography (IA, SEC, RP, HIC, IEX); glycosylation (monosaccharide/sialic acid/N-linked glycan); spectroscopy (UV/Vis, luminescence); protein expression, electrophoresis, quantification, ELISA, cell-based assays, enzyme kinetics; recombinant expression/construct design (mammalian hosts a plus); recombinant protein purification a plus.
Potential Base Pay Range
- $200,000—$226,000 USD