Senior Scientist - Analytical Methods & Strategy (12-Month Contract)
Global Biopharmaceutical Company
A leading global biopharmaceutical organisation is seeking a Senior Scientist to join its Analytical Methods & Strategy (AMS) group on a 12-month contract. This is an excellent opportunity for an experienced analytical scientist to support the commercial readiness of biologics programmes and contribute to method lifecycle activities across a world-class network.
The Role
Working within the Method Lifecycle Group, you will take ownership of analytical methods transitioning from clinical development into commercial manufacture. This is a varied position involving laboratory work, data analysis and cross-functional collaboration. You will support method qualification and validation, lead method transfers, and provide scientific input to ensure the robustness and regulatory compliance of commercial analytical methods.
Key Responsibilities
Provide technical oversight and ownership of analytical methods, partnering with analytical development to ensure method readiness for validation.
Support validation activities, including reviewing protocols, gathering data from development and QC teams, and assisting with validation reports.
Lead complex projects and guide a team of scientists to meet key milestones.
Oversee method revisions and drive method transfers to internal and external GMP QC laboratories.
Support the management of critical reagents for assigned methods.
Contribute to periodic method performance reviews and design improvement or remediation studies where required.
Review method summaries for regulatory submissions and assist with Health Authority queries.
Work collaboratively across sites to support method readiness, troubleshooting and technical alignment.
About You
Strong hands-on experience with protein separation techniques such as CE-SDS, iCIEF, HPLC/UPLC, including SEC, ion exchange and UV/Vis-based methods.
Good understanding of protein characterisation approaches including peptide mapping and carbohydrate analysis.
Experience leading complex projects with the ability to deliver against tight timelines.
Demonstrated critical thinking, attention to detail and strong organisational skills.
Experience in method validation and method transfer is desirable.
Comfortable working independently and within a matrixed, cross-functional environment.
Excellent communication skills with the ability to present data and influence stakeholders.
Qualifications
Degree in pharmaceutical sciences, bio-analytical sciences or related discipline.
MS/PhD with 5+ years' experience is desirable.
The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1 6498546
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