Principal Scientist – Analytical Development, Biologics

Location
:
Cambridge/Boston, MA - flexible hybrid model with regular on-site collaboration, typically at least one day per week

Reporting to
:
Director of Analytical Development, CMC

About Hemab

Hemab is building preventative treatments for serious, underserved bleeding disorders. These are therapies designed to work with the body's own biology and stop bleeds before they start, instead of treating them after they happen. We're patient-first, science-led and clinical-stage - with a pipeline that takes different scientific approaches to different patient needs.

We went public via our 2026 IPO, and we're scaling across two homes:
Cambridge, MA, USA, and Copenhagen, Denmark.

The role

As Principal Scientist, Analytical Development, you'll be the analytical lead supporting our biologics programs as they move from clinical development toward commercial readiness.

You'll set analytical strategy, guide GMP and QC work with our external partners, and utilize your expert judgement to work through method, validation and CMO challenges without waiting for someone else to define the answer.

What you'll do

• Own analytical strategy for biologics programs, with particular focus on the GMP, QC and validation work needed as programs progress toward commercial readiness.
• Lead analytical method transfer, optimization and validation with CROs and CDMOs, setting the strategy and making sure it is supported by the protocols.
• Guide external partners through analytical challenges, troubleshooting gaps in capability and keeping work moving when the answer isn't straightforward.
• Establish phase-appropriate analytical approaches, including setting and justifying specifications, product characterization, reference standards, stability protocols, comparability assessments and risk assessments.
• Ensure an appropriate mechanism of action-based potency assay is in place to support Phase 3 readiness.
• Provide analytical expertise on CMC sub-teams, working closely with Drug Substance, Drug Product, Research, Quality and Regulatory colleagues.
• Help shape process characterization work, including Critical Quality Attributes and appropriate validation of methods used for In-Process Controls.
• Lead and manage analytical CROs/CDMOs, material suppliers, consultants, vendors and collaborators; monitor regulatory trends, integrate new analytical approaches, identify opportunities to improve efficiency and reduce costs, and advise colleagues on data interpretation.
• Author and review analytical sections of regulatory submissions, including BLAs and MAAs, and represent Hemab as an analytical expert in regulatory interactions when needed.

What you’ll bring to Hemab

• Deep industry experience setting analytical strategy for biologics, particularly antibodies, with substantial exposure to late-stage development.
• Proven experience taking biologics programs through the analytical work required from late-stage development toward BLA and commercial readiness.
• Strong working knowledge of method development, product characterization, and comparability assessments, as well as GMP/QC analytical activities such as method transfer/validation and setting and justifying specifications.
• Significant experience managing CROs/CDMOs, including navigating technical problems where an external partner needs hands‑on guidance.
• Strong understanding of ICH expectations for stability and method validation, together with experience producing analytical content for regulatory submissions.
• Flexibility, a proactive approach and comfort operating in a fast‑paced biotech environment spanning multiple time zones.
• A relevant scientific degree, with a PhD preferred, and the technical depth to operate as an independent analytical expert.

Nice to have

• Experience with mechanism of action-based…