Specialist, Quality Control (Biologics, Copenhagen)

Job summary

The role involves serving as a technical lead and subject matter expert for Quality Control activities focused on drug products within the CMC Biologics team. The position requires collaboration with contract manufacturing organizations to implement and finalize QC activities, including sampling plans and method validation.

Qualifications

• Minimum 7 years of experience in the biotech or pharmaceutical industry.
• Accredited MSc or PhD in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equivalent.
• QC experience with drug products.
• Knowledge of the United States and European Pharmacopoeia, ICH guidelines, and GDP/GMP guidelines.
• Understanding of methods for testing biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA).
• Advanced English verbal and written communication skills.

Responsibilities

• Lead and oversee Quality Control activities related to drug products.
• Collaborate with CMOs to plan and execute QC relevant activities.
• Review and approve testing data, protocols, and reports.
• Support regulatory filings and interactions with Health Authorities.

Skills

• Strong collaboration and communication skills.
• Ability to work effectively in cross-functional and matrix teams.
• Quality mindset with a focus on continuous improvement.

Education

• MSc or PhD in relevant scientific fields.

Tools

• Familiarity with analytical testing methods and regulatory guidelines.