1. Our position
Analytical Lead
- Locationg: Geel
- Limited Remote working and up to 10% of travel expected
- Job type: Permanent
2. About the job
Our Team:
The Analytical function within global Manufacturing Sciences, Analytics and Technology (MSAT) is responsible for method development and supports method validation, all part of the Analytical Life Cycle Management (ALCM), within Sanofi Biologics network. We deliver innovative, robust, and cost-effective next generation analytical methods. We support the commercial manufacturing and the quality control departments through testing support, in-depth investigations, characterization testing, and comparability assessments. The function is responsible for analytical technology transfer activities including fit-gas assessment, method validation, prepare dossier sections, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins and nanobodies. In recent years we have successfully established second-generation manufacturing process with cona tinuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.
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Main responsibilities:
- Lead and oversee potency assays (including but not limited to bioassays, binding- and spectrophotometric assays) support for small scale studies, commercial biologics, LCM or second-generation programs for different Sanofi products
- Identify and implement method improvements to increase test turnaround time, reduce lab errors, or method robustness, and generation of a supportive data package leading to implementation in a quality control environment
- Develop new methods with focus harmonization between products (if possible), high throughput technology, PAT. Support method validation in QC.
- Support your team scientifically and proficiently as a people manager
- Actively maintain knowledge of industry best practices related to the cell and biochemistry potency assays. Interact with specialist within Sanofi and beyond.
3. About you
- Experience:
- You have relevant experience in the cell and biochemistry 'potency assays' of at least 3 years in MSAT-like functions
- Experience in managing direct reports as well as staff and activities in the network and matrix environment
- Technical skills:
- Hands-on experience in the potency assays in R&D and/or QC environment
- You are flexible and willing support local and global investigations and/or testing. You work efficiently in a matrix organisation.
- You are a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
- You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail
- You are familiar with various statistical and data trending techniques
- You like to work in team and consider yourself to be a good team player.
- Education:
- You have a PhD or master in Life Sciences, with relevant experience of minimum 3 years, in analytic development or MSAT-like functions
- Languages:
- Since all writing is in English and given the international context, you are fluent in writing and talking in English