Analytical Strategy & Lifecycle Scientist

I'm working on behalf of a leading BioPharma client seeking a highly motivated Analytical Strategy & Lifecycle Scientist for a 12-month contract role. This is a fantastic opportunity to contribute to key regulatory submissions, support analytical control strategies, and drive continuous improvement initiatives in a dynamic environment.

Key Responsibilities:

• Lead the planning, preparation, and management of analytical-related regulatory filings (BLAs, ROW submissions, PAS filings).
• Assist in compiling and reviewing analytical documentation for regulatory filings, ensuring quality and compliance.
• Collaborate with cross-functional teams (analytical development, manufacturing, regulatory, and quality) to ensure seamless execution.
• Track filing-related activities, milestones, and deliverables while providing key stakeholder updates.
• Support troubleshooting of analytical methods and contribute to specification management and method lifecycle activities.
• Participate in continuous improvement initiatives to enhance analytical processes and documentation.

Ideal Candidate:

• Experience in Analytical Strategy & Lifecycle, including JOS, Analytical Procedures, and Method Validation.
• Hands-on expertise with biological product assays (HPLC, iCIEF, electrophoresis, spectrometry techniques, ELISAs).
• Strong understanding of method qualification, validation, and regulatory guidelines (cGMP, compliance-focused).
• Excellent collaboration, communication, and technical writing skills.
• Ability to analyze complex data and work independently with initiative.

Qualifications:

• PhD, MS, or BS in Biological Sciences, Chemistry, or a related field with relevant experience.

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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