Description

Job Description

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.