Job Details

Main Tasks:

• Lead and develop the mass spectrometry laboratory ensuring scientific and technical excellence and operational efficiency to advance FK biosimilars development.

• Develop, establish and execute mass spectrometry protocols relevant to biosimilars' characterization and similarity assessment (intact mass, subunits analysis, PTMs, sequencing, peptide mapping, disulfide bridge mapping, etc.).

• Support analytical strategy adapted to development phases (early and late) as per regulatory guidelines. Provide mass spectrometry and molecular characterization expertise to stakeholders and project management teams.

• Be responsible for instruments' operations, calibration, maintenance, setting up of new methods and equipment, and method improvements. Troubleshoot issues with instruments and methods.

• Be in charge of method development, qualification, data acquisition, data analysis, and data interpretation. Apply data integrity principles of R&D QMS to enable compliant generation and reporting of submission-relevant data.

• Interpret and timely report results of work carried out in written and oral format both internally and externally. Review and approve operating procedures and analytical reports.

• Be responsible for planning of experiments, resource assignment / planning and delivery of results according project timelines.

• Provide project support, communicate project progress, seek alignment with other labs and escalate resource prioritization issues when needed.

• Manage performance and development of personnel to ensure achievement of goals, motivation, and productivity.

Qualification profile:

Education and languages

• University degree in the relevant area: PhD + minimum 4 years' experience or MSc + minimum 8 years' experience in the Biotech/Pharma industry.

• Fluent in English (spoken and written). French is a plus.

Professional skills and experience

• Strong experience and background in mass spectrometry mAb and recombinant protein characterization and method development

• Good understanding of monoclonal antibodies, their critical quality attributes and structure function relationships.

• Advanced knowledge and proven experience in peptide mapping, intact mass analysis and LC-MS workflows for the characterization of biotherapeutics. Fluency in proteomics approaches (identification and quantification).

• Proven experience in people management and stakeholders' management, a team player capable of analytical and critical thinking.

• Experience in evaluation and implementation of new technologies.

• Experience on the Thermo Q-Orbitrap FTMS platform is a plus.

Personal Skills and Competencies

• Ability to work accurately with attention to detail, in a highly organised manner.

• Ability to independently plan and prioritize activities and manages the time.

• Ability to work on multiple projects and flexibility to switch between projects.

• Ability to evaluate scientific data obtained at different stages of development.

• Shows initiative and proactive mind-set.

• Team worker and ability to maintain a highly motivating working atmosphere.