Manager / Senior Scientist Mass Spectrometry

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 manage 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.