Senior Biologics Analytics Lead - GMP Strategy & CRO Partner

Hemab Therapeutics; Cambridge (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Hemab Therapeutics is seeking a Principal Scientist, Analytical Development to lead analytical strategy for biologics programs as they move toward commercial readiness. You will guide GMP and QC work with CROs/CDMOs, define specifications, and ensure robust method transfer and validation.

You will also collaborate with Drug Substance, Drug Product, Research, Quality and Regulatory teams, shaping phase-appropriate analytical approaches and supporting regulatory submissions as a subject-matter

Qualifications

• Must have deep industry experience setting analytical strategy for biologics, especially antibodies.
• Experience taking biologics programs through analytical work to late-stage development and commercialization.
• Strong knowledge of GMP/QC analytics, method transfer/validation, and specification setting.

Responsibilities

• Own analytical strategy for biologics programs, especially GMP, QC and validation for commercial readiness.
• Lead analytical method transfer, optimization and validation with CROs/CDMOs and ensure supporting protocols.
• Guide external partners through analytical challenges and drive timelines when solutions aren’t straightforward.
• Establish phase-appropriate approaches, including specifications, reference standards, stability, comparability and risk assessments.
• Ensure an MOA-based potency assay supports Phase 3 readiness.
• Provide analytical expertise to CMC sub-teams across Drug Substance, Drug Product, and Regulatory groups.
• Contribute to process characterization, critical quality attributes, and In-Process Controls validation.
• Lead CRO/CDMO management, vendor oversight, and regulatory trend monitoring; support data interpretation.

Skills

Analytical strategy

Biologics development

CRO/CDMO management

Regulatory submissions

ICH stability & validation

Cross-time-zone collaboration

PhD or advanced degree

Education

PhD preferred

Scientific degree

Job description

Hemab Therapeutics is seeking a Principal Scientist, Analytical Development to lead analytical strategy for biologics programs as they move toward commercial readiness. You will guide GMP and QC work with CROs/CDMOs, define specifications, and ensure robust method transfer and validation.

You will also collaborate with Drug Substance, Drug Product, Research, Quality and Regulatory teams, shaping phase-appropriate analytical approaches and supporting regulatory submissions as a subject-matter