The Senior Mass Spectrometry Technical expert will provide technical leadership in the protein characterization group, designing and overseeing product characterization and quality control programs in the laboratory.
The ideal candidate will be responsible for the strategic direction of the group and will oversee research activity to ensure that methodologies remain at the cutting edge of technology. This role will also involve leading, managing and driving the TQA promise, demonstrating expertise across technical areas and providing support and guidance on specific techniques to both colleagues and clients.
The Senior Mass Spectrometry Technical Expert will work closely with the Laboratory Management and Business Development teams to manage the technical content of proposals, ensuring scientific integrity of data, and facilitate the progress of projects or studies while liaising with key members both within the laboratory and across the wider business, while maintaining a collaborative approach which provides solutions and not ‘blockers’ and is supportive in nature.
• Provide technical expertise within the biologics characterization team, responsible for designing studies and ensuring the scientific integrity of multiple analytical projects undertaken by the laboratory.
• Provide strategic direction to ensure that our services remain the best possible solutions for our clients within the biopharmaceutical industry.
• Lead R&D activities within the Biologics team, producing research material for publication and presentation at industry events.
• Author and/or critically review analytical project reports in a speedy and efficient manner regarding accurate interpretation of the data and compliance with the Analytical Project Plan.
• Ensure that all Quality Management documentation is completed in a timely manner.
• Assist the Laboratory Manager in establishing Development Training plans for all team members.
• In conjunction with the Project Manager and Laboratory Manager, plan and organize analytical workload for themselves and other members of staff for whom they provide supervision, based upon business priorities and specific project deliverables.
• Carry out project team briefings at the start of each project to explain the context of the project, define the deliverables and explain any specific testing requirements.
• Carry out Team Debriefings (review) with team members at the end of each project to discuss best practice and learnings which could be applied to future projects.
• Liaise with the Quality Group to advise of any atypical project timelines or requirements.
• Communicate effectively with staff at all levels, regularly with Laboratory Managers, Project Managers, and clients where applicable, providing detailed project status updates.
People Management Responsibilities:
• Drive performance through setting clear performance expectations.
• Manage performance through regular communications including one to ones, team meetings, and regular feedback.
• Set a high-performance culture.
• Take charge in releasing the potential of the team.
• Build meaningful relationships within the laboratory and wider business, liaising with others in a positive manner through collaboration and be accountable for providing key information or progress updates to ensure that work is completed effectively and without compromise.
• Build relationships and contacts to facilitate future exchange of information.
Required Skills and Experience:
• Strong understanding of protein chemistry and analytics and to be confident in designing experiments to establish the pertinent physiochemical and structural properties that must be evaluated during characterization and on-going quality control to ensure the continued product quality.
• A solid understanding of the requirements of ICH Q6B and a minimum of 5 years relevant experience of one or more of the following analytical disciplines:
LC-MS, including HRMS for elucidation of intact mass, protein/peptide sequencing, PTMs including oxidation, deamidation or glycosylation and disulphide bridge mapping.
Biophysical analytics including one or more of the following, AUC, CD, SEC-MALS, DSC or Fluorescence for assessment of higher order structure including aggregation.
Chromatography and/or electrophoresis for protein quantification