Senior CMC Specialist, Downstream Processing (Biotechnology, Copenhagen)

Job summary

The role involves contributing to lifecycle management and downstream processing strategies for marketed and late-stage biopharmaceutical products. The position requires collaboration with cross-functional teams and external partners to ensure compliance with regulatory standards and support commercial manufacturing activities.

Qualifications

• Degree in Life Science (Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related fields).
• Minimum 3 years of experience in downstream CMC for CMC Specialist level; 7 years for Senior CMC Specialist level, with a focus on late-stage development and lifecycle management.

Responsibilities

• Develop and maintain downstream processing strategies focused on lifecycle management.
• Serve as the downstream processing Subject Matter Expert (SME) for lifecycle management activities, including batch review and process comparability.
• Evaluate process performance and manufacturing trends related to downstream processing.
• Define the scope of downstream development activities with CMOs and partners.
• Oversee downstream activities at partnered CMOs, providing troubleshooting and commercial process support.
• Author and review CMC regulatory submission documents and responses to health authority inquiries.
• Collaborate with upstream processing and other SMEs to align lifecycle management strategies.
• Support continuous improvement of internal processes related to downstream lifecycle management.

Skills

• Strong understanding of mammalian downstream processes, including chromatography and TFF operations.
• Knowledge of process characterization, risk assessment, and process validation.
• Experience with lifecycle management activities and preparing CMC documentation for regulatory submissions.
• Strong communication skills in English.

Education

• Degree in Life Science or related field.

Tools

• Familiarity with regulatory submission processes and industry standards.