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 Drug Substance Senior Specialist with strong experience in biologics process development and validation. You will play a key role in driving process characterization, validation, and technology transfer for antibody programs in close collaboration with our CDMOs.
This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to commercial readiness.
Key Responsibilities:
Early-Stage Development
- Support early-stage antibody programs by applying phase-appropriate development strategies.
- Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches.
- Provide technical input to CDMOs on process design, scale-up, and risk assessments.
Process Characterization & Validation
- Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs.
- Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights.
- Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations.
- Support implementation of continuous process verification (CPV) and lifecycle validation strategies.
Late-Stage Development & Technology Transfer
- Oversee technology transfer to external manufacturing partners for commercial readiness.
- Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy.
- Coordinate comparability studies and process optimization activities with CDMOs.
Continuous Improvement
- Monitor regulatory trends and integrate new validation approaches.
- Identify and execute opportunities for process optimization and cost reduction.
- Share best practices and mentor colleagues in validation science.
Qualifications:
Education & Experience
- Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field.
- 8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs.
Technical Expertise
- Proven experience with PPQ and process characterization for antibody drug substances.
- Solid understanding of ICH Q8–Q11 and global validation expectations.
- Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions.
- Experience in early-stage process development and scale-up.
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.
Working Conditions
- Travel: ~15 days per year (flexible)
- Reports to: Emil Poulsen, Director of Drug Substance Development, CMC
- Team: CMC and Manufacturing
