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
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland