Principal Scientist - Analytical Development, Synthetics

Hemab Therapeutics; København; On-site; DKK 1,100,000 - 1,600,000; Full time

Job summary

Hemab Therapeutics, a clinical-stage biotech, is seeking a Principal Scientist, Analytical Development to lead analytical strategies for synthetic therapeutics including peptides and oligonucleotides. You will drive phase-appropriate method development, set specifications, and lead regulatory submissions from early development through commercial readiness.

You will oversee CROs/CDMOs, collaborate with Drug Substance/Drug Product teams, and contribute to NDAs/MAAs.

Qualifications

• Proven industry experience setting analytical strategy for synthetic therapeutics (peptides & oligonucleotides).
• Strong knowledge of phase-appropriate analytical method development and validations, specs, characterization, and regulatory submissions (NDAs/MAAs).
• Significant experience managing CROs/CDMOs, including guiding external partners.
• Solid understanding of ICH expectations for stability and method validation, with regulatory-submission experience.
• Ability to operate across multiple time zones in a fast-paced biotech environment.

Responsibilities

• Own analytical strategy for synthetics programs from first-in-human through commercial readiness.
• Establish phase-appropriate analytical approaches and specifications, characterization, stability, and risk assessments.
• Provide technical input to CDMOs on method development and validation for purity and product characterization.
• Manage analytical method transfer, optimization, and validation with external partners for commercial readiness.
• Lead CROs/CDMOs, suppliers, consultants and vendors; monitor regulatory trends and identify efficiency improvements.
• Author and review analytical sections of regulatory submissions (NDAs/MAAs) and represent Hemab in regulatory interactions.

Skills

Analytical strategy

Synthetics analysis

CRO/CDMO management

Regulatory submissions

Education

PhD preferred

Scientific degree

Job description

Location: Copenhagen, Denmark

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 use your extensive experience in the analysis of synthetic therapeutics, including peptides and oligonucleotides, to serve as the analytical lead supporting our synthetics programs from first-in-human through commercial readiness.

You will support both early- and late-stage development, including phase-appropriate method validations and Quality Control activities, setting and justifying specifications, process and product characterization, and preparation of CMC regulatory submissions, including NDAs and MAAs. You will drive analytical strategies and manage analytical activities across multiple CROs and CDMOs, helping to ensure smooth progression from clinical manufacturing to commercial readiness.

What You'll Do

• Own analytical strategy for synthetics programs, particularly peptides and oligonucleotides, from first-in-human through commercial readiness.
• Establish phase-appropriate analytical approaches, including setting and justifying specifications, product characterization, impurity marker synthesis and qualification, reference standards, stability protocols, comparability assessments and risk assessments.
• Provide technical input to CDMOs on method development and validation (especially for purity methods), as well as product characterization.
• Manage analytical method transfer, optimization and validation with external partners, including in support of commercial readiness.
• If appropriate, 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.
• Provide analytical support for process characterization, including determination of Critical Quality Attributes and appropriate validation of methods for testing 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, from first-in-human through NDAs and MAAs, and represent Hemab as an analytical expert in regulatory interactions when needed.

What You'll Bring To Hemab

• Proven industry experience setting analytical strategy for synthetic therapeutics, particularly peptides and oligonucleotides, with substantial exposure to late-stage development through commercialization.
• Strong working knowledge of phase-appropriate analytical method development and validations, setting and justifying specifications, product characterization, impurity marker synthesis and qualification, comparability assessments and regulatory submissions, especially NDAs/MAAs supporting late-stage synthetic programs.
• 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.
• Experience establishing reference standards.

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 position spans early- and late-stage development and works across multiple internal teams, CROs, CDMOs, suppliers, consultants, vendors and collaborators. Hemab operates across multiple time zones.

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.

Equal Employment Opportunity

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.