Quality Control Professional (Biologics, Mid-Senior Level, Valby)

Job summary

The role involves supporting the quality control (QC) processes for biologics, focusing on stability testing and vendor management. The position is essential for ensuring quality in the expanding portfolio of biologics commercial products.

Qualifications

• MSc or PhD in a relevant scientific discipline with over 5 years of experience.
• Familiarity with cGMP, ICH, pharmacopoeias, and related guidelines.
• Experience in stability testing of biologics.
• Proficient in English, both written and verbal.
• Background in QC vendor management.

Responsibilities

• Participate in the stability testing program and manage critical project activities, including shelf-life extensions and addressing authority inquiries.
• Oversee vendor management tasks such as change control and deviation handling.
• Manage external release and stability testing with multiple Contract Manufacturing Organizations (CMOs) and Contract Test Laboratories (CTLs).
• Support the transition of biologics development candidates to commercial manufacturing and guide related analytical activities.
• Engage in international travel (approximately 5 days per year) to collaborate with CMOs and CTLs.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and collaboration abilities.
• Ability to work in a fast-paced, project-oriented environment.

Education

• Advanced degree (MSc or PhD) in a relevant scientific field.

Tools

• Familiarity with quality control software and laboratory equipment relevant to biologics testing.