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 while facilitating the progress of a project or study, liaising with key members both within the Laboratory and across the wider business. You will maintain 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 evaluated during characterization 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 clearly and to build rapport quickly and effectively.
Full understanding or experience of the regulatory requirements or ‘Good Working Practices’ which 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 many different disciplines, so you will advance your skills and knowledge in material characterization analysis.
Key activities:
Provide technical expertise within the biologics characterization 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 on 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 De-briefings (review) with team members at the end of each project to discuss best practices 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.
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 we thrive 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 do 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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