Healthcare ASL Scientist

What are we looking for in our ASL Scientist?

Job Title: ASL Scientist
Duration: 12 months
Location: Dublin 15

Position Summary:

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.

Key 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.

Qualifications & Experience

·       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

Education/Experience/ Licenses/Certifications:

·       A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with experience within Analytical Strategy & Lifecycle / relevant field, respectively