Principal Scientist – Analytical Development, Biologics

HiTalento TALENTO ApS; Cambridge (MA); Hybride; USD 180 000 - 270 000; Plein temps

Résumé du poste

Hemab Therapeutics in Cambridge, MA is seeking a Principal Scientist to lead analytical development for biologics as programs advance toward clinical and commercial readiness. You will shape analytical strategy, oversee GMP/QC activities, and guide CROs/CDMOs while solving complex method validation challenges.

Collaboration across Drug Substance, Drug Product, and Regulatory teams is essential. Regular cross-time-zone collaboration and on-site presence at least one day per week are expected as

Qualifications

• Extensive experience setting analytical strategy for biologics, especially antibodies.
• Proven track record leading CROs/CDMOs and managing external analytical testing.
• Experience producing analytical content for regulatory submissions (BLAs/MAAs).

Responsabilités

• Own analytical strategy for biologics programs through late-stage development and readiness for commercial use.
• Lead method transfer, optimization and validation with CROs/CDMOs and ensure protocol support.
• Guide external partners through analytical challenges and keep work moving when solutions are not straightforward.
• Establish phase-appropriate analytical approaches, including specifications, reference standards and stability protocols.
• Ensure potency assays support phase 3 readiness and work with cross-functional teams.
• Contribute to regulatory submissions and interact with authorities as needed.
• Manage data interpretation, process characterization, and risk assessments.
• Lead CRO/CMO relations, monitor regulatory trends, and seek efficiency/cost improvements.

Connaissances

Biologics strategy

CRO/CDMO management

Regulatory submissions

Formation

PhD in a relevant field

Description du poste

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 potency assays, particularly non‑cell‑based assays.

What to expect, honestly

Hemab is still building a lot of its own structure. Systems here tend to get created as we need them, not handed down in advance. You will likely build some of your own tools and processes instead of inheriting finished products. We work across two hubs and multiple time zones - bridging that well takes real, deliberate effort. And because we're growing quickly, priorities can shift with less notice than they would at a larger, more established company.

This role comes with considerable autonomy. You'll be trusted to work out what needs to happen, bring a point of view and ask for input when it's useful. You'll also work closely with colleagues in Cambridge, so regular time together matters. We expect at least one day per week in the office, with flexibility around how you use on-site time. Travel is approximately 30 days per year.

Why Hemab

At Hemab, your work ultimately connects back to something simple. People living with serious bleeding disorders get something they've never had before - the chance to prevent a bleed, instead of reacting to one after it happens. You'll be joining at a stage where individual decisions still carry real weight, and where your work can help turn promising science into a preventative treatment that actually reaches patients.

How we treat our people is meant to be an extension of how we think about patients: with care, honesty, and respect. We're still building the consistency to back that up across every hiring process, every time. We'd say that plainly instead of pretending otherwise. If any part of your experience with us falls short of it, tell us.

Hemab builds balanced candidate slates and assesses everyone against a single standard. If you need a reasonable adjustment at any stage of the hiring process, please tell us.

Hemab Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Please answer in your application:

Have you managed external CDMOs delivering GMP/QC analytical testing for biologics?

Principal Scientist - Analytical Development, Biologics