Principal Scientist – Analytical Development, Synthetics

HiTalento TALENTO ApS; København; On-site; DKK 1,000,000 - 1,500,000; Full time

Job summary

Hemab Therapeutics, based in Copenhagen and Cambridge, seeks a Principal Scientist - Analytical Development, Synthetics to lead analytical strategy for synthetic therapeutics (peptides/oligonucleotides) from first-in-human to commercial readiness.

You will drive method development/validation, QC, and regulatory submissions (NDAs/MAAs), and oversee CROs/CDMOs across time zones to ensure smooth progression to commercialization.

Qualifications

• Extensive experience setting analytical strategy for synthetic therapeutics (peptides/oligos).
• Late-stage development through commercialization exposure.
• Experience with external CDMOs/CDRMs and regulatory submissions.
• Independent analytical expert capable of leading cross-functional teams.

Responsibilities

• Own analytical strategy for synthetics programs, peptides and oligonucleotides, from first-in-human through commercial readiness.
• Establish phase-appropriate analytical approaches, including specifications, characterization, impurities, reference standards and stability.
• Provide technical input to CDMOs on method development and validation (purity methods).
• Manage analytical method transfer, optimization and validation with external partners for commercial readiness.
• Ensure mechanism of action-based potency assay if needed for Phase 3 readiness.
• Provide analytical expertise on CMC sub-teams across Drug Substance/Product, Q&R.
• Support process characterization and validation of In-Process Controls.
• Lead and manage CROs/CDMOs, suppliers, vendors; monitor regulatory trends and costs.
• Author/regulatory submissions for NDAs/MAAs as analytical lead.

Skills

Analytical strategy

Synthetics expertise

CRO/CDMO mgmt

Regulatory submissions

ICH stability knowledge

Education

PhD in relevant field

Job description

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.

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.

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 analytical testing for synthetic drugs?

Principal Scientist - Analytical Development, Synthetics