Celonic is a privately owned Contract Development Manufacturing Organization (CDMO) with two state-of-the-art sites located at Basel, Switzerland (headquarters) and Heidelberg, Germany.
Celonic provides comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars, as well as Cell & Gene Therapy associated services worldwide. Their portfolio includes the development of cell lines, production processes, as well as non-GMP and GMP manufacturing of biopharmaceutical drug substances and drug product. Currently there are over 300 highly qualified employees working at the two sites of Celonic. Because of the expansion of the company, Celonic is looking for dedicated and qualified employees.
To support our Downstream Processing Development Team at our Basel site (Switzerland) we are looking for a
Senior Scientist Extracellular Vesicles/ lipid nanoparticles (f/m/d)
Your area of responsibility:
- Develop exosome isolation platforms and technologies for ATM production
- Direct and conduct studies, tabulate and analyze results to improve yield, purity, and quality of EVs/exosome products. This role will focus on developing novel purification protocols and characterizing samples
- Evaluate EV testing as needed during process development and scale up to achieve required quality attributes of EVs/exosomes.
- Plan, execute experiments and prepare technical reports, summaries, protocols, and result analyses.
- Involvement and interaction with customer throughout current and potential projects
- Develop, optimize and scale-up state of the art GMP-compliant production steps for EV drug delivery systems
- Support technology transfer of process to manufacture GMP batches for toxicology and clinical studies as necessary
- Collaborate in multi-disciplinary project teams with Project Management, Development, Marketing, Process Development, Regulatory, etc.
- Generate and maintain technical reports, SOPs and URS documents
Your skills & qualification:
- BSc./MSc. with 6 to 8 years of experience in DSP with at least 4 years of experience (PhD with 2 to 5 years preferred) in lipid nanoparticles and/or other non-viral delivery systems (e.g. EVs/exosomes) used as gene therapeutics)
- Experience in mammalian cell-based processing, products and characterization.
- Expertise in isolation and physical and biological characterization of exosomes
- Good understanding of cellular trafficking mechanisms in general as well as vesicle uptake and trafficking and endocytic pathways
- Experience in evaluation of analytical results derived from DLS, NTA, encapsulation assay, gel/capillary electrophoresis, HPLC/UPLC, Mass Spectrometry, etc.
- Comfortable operating AKTA chromatography systems and method writing in Unicorn software
- Must be capable of working independently as well as in a collaborative/group environment
- Good communication and interpersonal skills
- Ability to multi-task in a fast-paced work environment
- Strong commitment to accountability with can-do attitude for completion of projects in accordance with team plans and timelines