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Drug Substance Senior Specialist – Biologics

Denmark, København og omegn · Job Posted January 05, 2026
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Job Description

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.

Job Responsibility

  • 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
  • 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
  • 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
  • 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

Requirements

  • 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
  • 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
  • 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
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