ASL Scientist, Analytical Strategy & Lifecycle

PE Global is currently recruiting for an Analytical Strategy & Lifecycle for a leading multi-national Pharma client based in Dublin. This is a contract position.

Role:
We are seeking a highly motivated Analytical Strategy & Lifecycle Scientist for a 12-month contract position within our dynamic team. This role is responsible for the planning, preparation, and management of analytical-related regulatory filings across our diverse portfolio. The ideal candidate will collaborate with cross-functional teams, including analytical development, manufacturing, regulatory, and quality, to ensure the timely and high-quality delivery of filing-related documentation. This position offers the opportunity to contribute to key regulatory submissions, support analytical control strategies, and drive continuous improvement initiatives. If you are a detail-oriented professional with a passion for excellence in analytical science and regulatory compliance, we encourage you to apply.

Responsibilities:
· Planning and Coordination of Analytical Filings: Lead the planning, preparation, and management of analytical-related regulatory filings across the portfolio, including support for BLAs, ROW submissions, and PAS filings.
· Regulatory Submission Support: Assist in compiling and reviewing analytical documentation required for regulatory filings, ensuring alignment with project timelines and quality standards.
· Stakeholder Collaboration: Work closely with cross-functional teams, including analytical development, manufacturing, regulatory, and quality, to ensure seamless delivery of high-quality analytical strategies.
· Tracking and Reporting: Maintain clear and accurate tracking of filing-related activities, milestones, and deliverables, providing regular updates to key stakeholders.
· Support for Analytical Activities: Contribute to the preparation and implementation of analytical control strategies, including specification management and method lifecycle activities.
· Issue Resolution: Collaborate with QC and other teams to support troubleshooting of analytical methods, addressing issues impacting regulatory filings or project deliverables.
· Continuous Improvement: Participate in initiatives to improve the efficiency and quality of analytical-related processes and documentation.
· Documentation Oversight: Ensure all filing-related documentation complies with internal standards, regulatory requirements, and best practices.
Requirements:
· A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with experience within Analytical Strategy & Lifecycle / relevant field, respectively

· Requires working knowledge of the relevant principles and concepts of Analytical Strategy & Lifecycle (JOS / Analytical Procedures / Method Validation etc.) and associated GMP’s.
· Understanding and industry hands-on experience with a broad range of assays for testing and characterizing biological products, such as HPLC, iCIEF, gel and capillary electrophoresis, and various spectrometry techniques (e.g., MS, absorption), along with ELISAs.
· An understanding of method qualification and validation, underpinned by an understanding of regulatory guidelines and a commitment to cGMP laboratory operations, ensuring compliance across all activities.
· Demonstrated ability to collaborate effectively with remote colleagues and within a matrix organizational structure, supported by excellent written and verbal communication skills.
· Demonstrated capability to analyze complex data and draw actionable conclusions, coupled with proficiency in authoring formal reports, technical documents, and scientific communications, highlighting strong analytical and writing skills.
· Ability to work independently on a majority of Analytical Strategy & Lifecycle tasks, showing a degree of initiative and responsibility in a regulatory-compliant manner
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***