Senior Scientist, QA for QC

Are you driven by the purpose of the biopharmaceutical industry and eager to make a difference for patients worldwide through your impact on the Quality and Quality Assurance (QA) agenda? Would you like to accelerate your career as a Senior QA Scientist and learn and grow in a function that supports Quality Control (QC)? As a Senior Scientist in QA for QC, you will be located at our facility in Søborg, Copenhagen, and take a leading role in the quality assurance of QC documentation, manufacturing activities, and batch release. If you are excited about building further on your GMP experience and joining an international CDMO, then this might be the right opportunity for you!

You will be supporting QC, the entire organization & international customers

You will be joining the QA Department, consisting of over 80 colleagues, with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment. The main responsibility of the QA for QC team is the quality assurance of QC documentation, manufacturing activities, and batch release. We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim to constantly ensure that QC and manufacturing follow current standards for GMP production, i.e., EU GMP, 21 CFR, and ICH guidelines.

The QA for QC team consists of nine highly dedicated Scientists with various professional backgrounds in natural sciences and many years of QA experience. We are known for fostering open communication with a focus on a high level of professionalism. A key to the success of our team is about being open-minded and highly supportive of our colleagues in the rest of AGC Biologics, as well as our international customers. Therefor, the QA for QC team is characterized by positive and proactive colleagues who meet deadlines through committed and friendly collaboration. Joining this team really gives you the opportunity to learn and grow from your responsibilities as well as from the great colleagues that surround you every day in the team and across QA!

AGC Biologics offers a dynamic environment with a growing responsibility

If you thrive in a dynamic environment with new and challenging tasks along the way, this QA Senior Scientist role could be relevant to you. You will be joining a department which is driven by demonstrating problem-solving skills, reliability in meeting commitments, and providing exceptional customer experiences. It is all about balancing a very high level of quality without compromises while holding a pragmatic attitude towards problem-solving and collaborations. If you recognize yourself upholding that balance, this role could be very suitable for you. We will involve you in various daily operational tasks and make sure that you are supported as you need. Your main responsibility will be ensuring a close collaboration with QC, other QA teams, and QP. You will be guiding on requirements for commercial production support. You will be actively involved in laboratory investigations, deviations, handling change controls and CAPAs. In time and based on training and distribution of tasks across the team, you will also review and approve analytical method validation protocols and reports.

We highly value your QA and GMP experience

Joining a scientifically knowledgeable and skilled team gives you great options for continuous sparring and development. It is therefore a significant advantage if you hold a Master's degree from a relevant field of studies in natural science, e.g. Pharmacy, Biotechnology, Biology, Chemistry, or similar.

We will make sure to build further on your QA experience, which you could bring from QC as well as API or Adjuvant manufacturing. You will get quickly into your new responsibilities if you have experience with QA oversight in QC activities and providing staff guidance, QA or QC analytical method validation, reviewing and evaluating QC documentation, and deviation handling, including root cause investigations. Also, your in-depth knowledge of GMP requirements will be a key foundation for your training with us, regardless if you come from a commercial and/or late-stage clinical phase manufacturing of biological intermediates, APIs, or Cell Banks. The combination of QA and GMP competencies that we are looking for, typically translates into +5 years. English is our company language, and in this role, fluency in written and spoken English is a key requirement in order to ensure effective communication with our international customers.