Biological Characterisation Technical Expert

ABOUT YOU

You will have accountability for leading, managing and driving the TQA promise. You will demonstrate your expertise across technical areas and have the confidence to provide support and guidance on specific techniques to both Colleagues and Clients.

Working alongside the Laboratory Management and Business Development teams, you will manage the technical content of proposals and ensure the scientific integrity of data as well as facilitate the progress of a project or study whilst liaising with key members both within the Laboratory and across the wider business, maintaining a collaborative approach that provides solutions and is supportive in nature.

Required skills and experience:

• Strong understanding of protein chemistry and analytics, confident in the design of experiments to establish the pertinent physiochemical and structural properties that must be evaluated during characterisation and ongoing quality control to ensure continued product quality.
• A solid understanding of the requirements of ICH Q6B with relevant experience in 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 and impurity assessment.
• Ensure that all processes are aligned to the needs of the Client and fit with the schedule of works.
• Strong experience of creating methods from end to end with minimal support or guidance across multiple projects.
• Solutions focused with the ability to independently troubleshoot and source solutions, conveying these to both Clients and members of the business in a methodical and simplistic way.
• Clear written and verbal communication skills with the ability to convey processes, results and key messages and build rapport quickly and effectively.
• Full understanding or experience of the regulatory requirements or ‘Good Working Practices’ that apply to the pharmaceutical industry.

ABOUT THE OPPORTUNITY

You will work autonomously to test different materials that can include active pharmaceutical ingredients, excipients, process intermediates, finished dosage forms and packaging materials. Our work spans across many different disciplines, allowing you to advance your skills and knowledge in material characterisation analysis.

Key activities:

• Provide technical expertise within the biologics characterisation team, responsible for the design of studies and the scientific integrity of multiple analytical projects undertaken by the laboratory.
• Provide strategic direction to ensure 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 timely manner regarding accurate interpretation of data and compliance with the Analytical Project Plan.
• Ensure that all Quality Management documentation is completed promptly.
• Assist the Laboratory Manager in establishing Development Training plans for all team members.
• In conjunction with the Project Manager and Laboratory Manager, plan and organise analytical workload for themselves and other members of staff for whom they provide supervision, based on business priorities and specific project deliverables.
• Carry out project team briefings at the start of each project to explain the context, define deliverables and explain specific testing requirements.
• Conduct Team De-briefings with team members at the end of each project to discuss best practices and learnings applicable 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.

WHAT WE OFFER

Join Intertek and become part of our global network of inspiring and entrepreneurial colleagues. We are a global family that values diversity and thrives working together with precision, pace, and passion. We are working to make the world Ever Better, ensuring the quality, safety and sustainability of products and services used by millions of people around the world.

• Competitive salary/benefits
• Development and career opportunities around the Globe
• Working in a highly motivated team and dynamic working environment

We are an Equal Opportunity Employer who does not discriminate against applicants. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin.

Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies.

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