Drug Substance Senior Specialist – Biologics

1 day ago

Copenhagen Metropolitan Area, Denmark Hemab Therapeutics Full time 80,000 - 120,000 per year

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

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