Principal Scientist – Analytical Development

About Hemab

Hemab is a clinical-stage biotech company on a mission to develop innovative treatments for neglected bleeding and thrombotic disorders. With sites in Copenhagen and Boston, we combine high-impact science with a collaborative culture as we progress toward commercialization.

Position Summary

We are seeking a Principal Scientist to fill a specialist role in Analytical Development with strong experience in the analysis of biologics to support late-stage activities, including method validations/Quality Control activities to support commercial readiness, setting and justifying specifications, process and product characterization, and preparing CMC sections in regulatory submissions (BLAs/MAAs). You will play a key role in driving analytical development strategies and managing analytical activities at multiple CROs/CDMOs.

This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to commercial readiness.

Key Responsibilities

Early-Stage Analytical Development

Support early-stage biologics programs by applying phase-appropriate strategies for analytical development.

Collaborate with Drug Substance, Drug Product, Research, Quality, and Regulatory teams to align on required analytical support.

Provide technical input to CDMOs on method development and validation, setting and justifying specifications, early-stage product characterization, reference standard establishment, stability protocols, risk assessments, etc.

Author and/or review CMC sections of Phase 1/2 regulatory submissions.

Late-Stage Analytical Development

Manage analytical method transfer, optimization, and validation efforts with external partners to support commercial readiness.

Ensure an appropriate, mechanism of action-based potency assay is in place to support Phase 3 readiness (experience with non-cell-based potency assays is a plus).

Provide analytical support and guidance for process characterization activities, including the determination of Critical Quality Attributes, and ensure methods are appropriately validated for testing In-Process Controls.

Provide technical input to CDMOs on method validations, setting and justifying specifications, comparability assessments, late-stage product characterization, reference standard establishment, stability protocols, risk assessments, etc.

Prepare CMC sections for regulatory submissions (BLAs/MAAs) with emphasis on analytical sections; if necessary, represent the company as the analytical expert in interactions with regulatory authorities, including preparation of requests and responses.

Continuous Improvement

Monitor regulatory trends and integrate new analytical approaches.

Lead and manage the work of analytical CROs/CDMOs, material suppliers, consultants, vendors, and collaborators to support analytical activities.

Identify and execute opportunities to improve efficiency and reduce costs.

Share best practices and advise colleagues on data interpretation.

Qualifications

Education & Experience

Bachelor’s degree in a relevant subject (e.g. analytical chemistry, protein chemistry, chemistry, biochemistry, biotechnology, etc.) at a minimum, with a Master’s degree or Ph.D. preferred.

7+ years of industry experience in the analysis of biologics, especially at late-stage, and a strong history of collaboration with CDMOs.

Technical Expertise

Proven experience providing analytical support to biologics programs, especially antibodies, from first-in-human through commercialization.

Practical knowledge of phase-appropriate analytical method development and validations, product characterization, and comparability assessments

Direct experience with regulatory submissions such as BLAs/MAAs, ideally across multiple programs, especially to support late-stage biologics programs.

Solid understanding of ICH guidelines and pharmacopeias for stability and method validation expectations.

Experience with mechanism of action-based potency assays is a plus.

Experience establishing reference standards is a plus.

Skills & Competencies

Strong project management and organizational abilities.

Excellent communication and technical writing skills for regulatory documentation.

Collaborative mindset and ability to work effectively with external partners.

Flexible, proactive, and comfortable operating in a fast-paced biotech environment at a company spread out across multiple time zones.

Working Conditions

Travel: ~15 days per year (flexible)

Reports to: Rane Harrison, Director of Analytical Development, CMC

Team: CMC and Manufacturing

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