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
