Leading Quality Assurance Specialist for Biologics Development
9 hours ago
We are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics team at H. Lundbeck A/S in Copenhagen, Denmark.
About the RoleThis is an excellent opportunity for a seasoned professional to take on a key position in ensuring the quality of our development biologics drugs from Phase I to Phase III.
As Senior Quality Control Scientist, you will be responsible for technical leadership and subject matter expertise for 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.
- Review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.
- Collaborate within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs.
- Support regulatory filings and other interactions with Health Authorities.
This role offers a great opportunity to be part of a team that ensures the quality of our development biological drugs, working in close collaboration with global partners.
About YouTo succeed in this role, you should have a minimum of 5 years of experience in the biotech or pharmaceutical industry, with an accredited bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal.
- Experience in drug-device combination products.
- Familiarity with GDP/GMP guidelines.
- Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia.
- Understanding of methods used to test biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA).
- Advanced English verbal and written communication skills.
A salary in the range of €90,000 - €110,000 per year, depending on experience, is offered for this challenging position.
We are committed to creating a diverse and inclusive workplace that values employee well-being and growth opportunities.
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