Senior Quality Assurance Specialist
1 month ago
About the Role
We are seeking an experienced Senior Quality Control Scientist to join our CMC Biologics Quality Control team in Copenhagen, Denmark.
Job Description
In this role, you will be responsible for technical leadership and subject matter expertise in Quality Control activities with a focus on drug-device combination products. You will work closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities such as sampling plans, Certificate of Analysis, stability studies, method validation etc. Additionally, you will review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.
Your Key Responsibilities
- Technical lead for Quality Control activities with focus on drug-device combination products
- Collaboration with CMOs to plan, implement, and finalize QC relevant activities
- Review and approval of protocols, reports, and other documents
About the Team
You will be part of a team ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team. Our team is located in both Copenhagen and Seattle, and we aim to reduce late meetings to a minimum by maintaining a primary meeting band in the calendar and applying geographical proximity when working with global CMOs.
What We Offer
- A competitive salary of 110000-140000 DKK per year, depending on experience
- The opportunity to work with a diverse range of projects and teams within the company
- A collaborative and dynamic work environment
- The chance to develop your skills and career within the company
About H. Lundbeck A/S
Lundbeck is a research-intensive biopharmaceutical company with a long history of innovation and commitment to improving the lives of people affected by brain disorders. Our vision is to create a future where no one suffers from brain diseases.
Requirements
- Minimum 5 years of experience in the biotech or pharmaceutical industry
- Bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal
- Experience in drug-device combination products
- Good understanding of GDP/GMP guidelines
- Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia
- Understanding of methods used to test biological molecules
Apply Now
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