Stellenbeschreibung
Celonic is a “Pure Play” Biologics Contract Development Manufacturing Organization (CDMO). Celonic’s mission is to help its customers, primarily small to large Biotech Companies, bring life- saving and improving drugs effectively to the market using innovative, “next generation” bioprocessing technologies. Celonichas a state-of-the-art Biologics Development Center in Basel, Switzerland (headquarters), and clinical and commercial GMP manufacturing facilities in Heidelberg, Germany. At present, more than 500 highly qualified employees work at Celonic’s. Due to the expansion of the company, Celonic is looking for committed and qualified employees.
THE POSITION
Reporting to the Team Manager of analytical separation techniques within the Analytical Method Development group, the Analytical Scientist will be responsible for implementing and performing LC-MS methods to characterize and ensure the quality of biologics products (e.g., by peptide mapping, intact mass, N-glycan analysis…)
In this role, you will collaborate closely with Senior Scientists to develop and execute fit-for-purpose analytical methods that support process development units. The Scientist will also be responsible for implementing the developed methods as GMP-ready UPLC-based methods and supporting their transfer to quality control units. Acting as a subject matter expert for LC-MS-analytics, you will provide scientific and practical support to internal customers and serve as the primary point of contact for the planning, execution, troubleshooting, and optimization of MS-based analytical methods.
YOUR RESPONSIBILITIES:
– Design and perform LC-MS based analytical methods for large molecules (e.g., antibodies)
– Continuously improve current methods and workflows and scout innovative state of the art applications and technologies
– Act as subject matter expert & point of contact for LC-MS methods
– Organize and coordinate instrument maintenance, commissioning, and qualification
– Interpret experimental results and present findings to internal and external stakeholders
– Support planning, documentation, and execution of method transfers from non– GMP to GMP (QC)
– Support optimization, characterization and validation of LC-MS assays according to regulatory guidelines
JOB REQUIREMENTS:
– Biotechnology or Pharma industry experience (5+ years)
– Proven track record in LC-MS development, ideally in a biologics production setting (e.g., peptide mapping, N-glycan analysis), including data analysis and interpretation
– Experience in using UNIFI is a plus
– Demonstrated experience in working with autonomy and self-discipline to meet timelines.
– Demonstrated flexible and solution-focused mindset with strong operational, organizational, and documentation skills
– Confident in the use of Microsoft Office
– Confident in the use of English language (German is a plus)
– Experience in performing analytical method qualification/validation and knowledge of relevant guidelines (ICH, Pharmacopoeias, EMA, FDA) is a plus
WHY CELONIC?
– Make a difference by directly impacting patients lives
– Biologics is an attractive, high growth sector with professional development
– Offers a multinational and diverse workplace
– Proud to be a pioneer in “Next Generation” manufacturing technologies
– Family owned: Entrepreneurial, and short communication lines
– Basel is a great place to live, play and work in the center of Europe