Senior Quality Control Specialist (Biotech, Copenhagen)

Job summary

The role involves serving as a technical lead and subject matter expert in Quality Control activities, primarily focusing on drug substance within a global CMC Biologics team. The position supports various QC activities, including Process Performance Qualification and collaboration with contract manufacturing organizations.

Qualifications

• Minimum 9 years of experience in the biotech or pharmaceutical industry.
• Accredited MSc or PhD in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equivalent.
• Experience with drug substance PPQ and late-stage QC deliverables for BLA filing.
• Knowledge of the United States and European Pharmacopoeia, ICH guidelines, and GDP/GMP guidelines.
• Advanced English verbal and written communication skills.

Responsibilities

• Lead and oversee Quality Control activities related to drug substance.
• Support drug substance Process Performance Qualification (PPQ) activities.
• Collaborate with CMOs to plan and implement QC relevant activities, including sampling plans and method validation.
• Review and approve QC testing data, protocols, and reports.
• Collaborate with project teams across various functions including Regulatory CMC and Quality Assurance.
• Support regulatory filings and interactions with Health Authorities.

Skills

• Strong understanding of methods for testing biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF).
• Ability to work effectively in cross-functional teams and fast-paced environments.
• Strong verbal and written communication skills, with the ability to summarize scientific data clearly.

Education

• MSc or PhD in relevant scientific fields.

Tools

• Familiarity with analytical testing methods and regulatory guidelines relevant to biologics.