(Associate) Scientist GMP QC Lab
About the Opportunity
The GMP QC Lab of the Quality Department is looking for a (Associate) Scientist who acts as project lead for the GMP QC Lab in Nanobody programs. The main responsibilities are release, stability and in use testing of the pre-clinical, clinical and commercial materials under full GMP control.
Ablynx, a Sanofi Company
Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.
- You perform your activities in the Ablynx GMP QC Lab according to the Ablynx Quality System.
- You represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert.
- You are responsible for the qualitative technology transfer of analytical methods from a Transfer Unit to the Ablynx GMP Unit, or from the Ablynx GMP Unit to a Receiving Unit.
- You are responsible for the establishment of GMP Analytical Methods (such as SEC, RPC, IEX-HPLC, CGE, CE-IEF, UV spectrometry, compendial methods, and potency assays (ELISA or cell based assays)).
- You are responsible for the establishment of technical instructions of the systems used in the GMP QC Lab.
- You perform method qualification and / or validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You perform method life cycle management and keep oversight over methods performed on different sites.
- You perform technical review of analytical results, assist and guide the (Senior) Research Associates in technical problem solving and conduct OOx-investigations if required.
- You follow up on trending data and define appropriate actions if required.
- You suggest and develop new approaches and processes.
- You organize trainings as subject matter expert (on methods, laboratory systems).
- You are responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab.
- You write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory.
To excel in this role you will need to have:
- PhD with 3 years of post-doc experience in a relevant field of life sciences or MSc, Bio-engineer with 7 to 10 years of relevant experience.
- Fluent in Dutch and English, written and spoken.
- You combine technical expertise with good people management skills.
- You have experience in physico-chemical analysis and/or potency testing of proteins.
- Experience with method validation, method life cycle management, critical reagent management, stability studies and release testing is an asset.
- Experience with GMP guidelines and a GMP working environment.
- Knowledge of ICH and Pharmacopeia.
- Team player, enthusiastic, independent and self-motivated.
- Excellent communication and writing skills are required.
- Sense for initiative, quality, accuracy and detail.
What Sanofi can offer you
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.