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 Bioassays within the Analytical Method Development group, the Senior Scientist will be responsible for implementing state of the art ELISA methods to ensure the quality of biologics products, including monitoring product impurities, biologics content, and potency.
In this role, you will develop and execute fit-for-purpose analytical methods that support process development units. As the Senior Scientist , you will also be responsible for implementing GMP-ready methods and supporting their transfer to quality control units. Acting as the subject matter expert for assays, 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 plate-based analytical assays.
YOUR RESPONSIBILITIES:
– Design and perform plate based assays (e.g ELISA) as part of analytical method development
– Create standardized data evaluation templates and standard operating procedures for use in GMP quality control
– Act as subject matter expert & point of contact for plate based assays
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)
– Take a leading role in optimization, characterization and validation of plate based assays according to regulatory guidelines
JOB REQUIREMENTS:
– M Sc / PhD or equivalent in a life science discipline (e.g. Biotechnology, Biochemistry, Biomedicine)
– Biotechnology or Pharma industry experience (3+ years; CDMO background is a plus)
– Proven track record in plate based assay development, ideally in a biologics production setting (e.g. titer-ELISAs, HCP- / residual-ELISAs) including data analysis and interpretation
– Experience in performing analytical method qualification / validation
– Knowledge of relevant guidelines (ICH, Pharmacopoeias, EMA, FDA)
– Demonstrated experience in working in autonomy and self-disciplined to meet timelines.
– Full professional proficiency in the English language (German is a plus)
– Demonstrated flexible and solution-focused mindset with strong operational, organizational and documentation skills
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