Drug Substance Senior Specialist - Biologics (Antibodies)

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