Analytical Sciences Associate Specialist

Job Description

Our Carlow site, which broke ground in 2008, is a strategic manufacturing facility supporting the launch and commercial supply of vaccines, biologics, and small molecule drug products.

Since its establishment, the site has benefited from significant investment and is home to state-of-the-art manufacturing facilities, laboratories, and temperature-controlled warehousing. As a major employer in the Southeast region, the Carlow site attracts high-performing talent through strong collaborations with local universities and colleges.

We are currently seeking an Analytical Sciences associate specialist to join the team, you will be responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management; including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale.

This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations and biochemistry.

Bring energy, knowledge, and innovation to carry out the following:

• New method introduction (Validation /Tech Transfer).
• New technology introduction.
• Assessment and implementation of changes for existing methods and equipment: Change in technical element of method e.g. Parameter change, Change in equipment element of method e.g., column/reagent change.
• Method troubleshooting where cross-functional investigation is required.
• Technical SME for regulatory questions, audit support, reagent changes / supply issues to provided justification / rationale for analytical methods and equipment.
• Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / Compendia changes or updates.
• Analytical equipment troubleshooting.
• Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed.
• Investigation support for lab investigations.
• Authoring technical documentation in support of investigation and regulatory responses.
• Technical Impact Assessment of proposed and finalized compendial changes.
• Development and ownership of change control for new analytical methods.
• Routine Assay Monitoring and lifecycle management of analytical methods.
• Supporting digital method development.

What Skills You Will Need

• Bachelor's degree in science or equivalent experience.
• 2-3 years relevant experience in the pharma industry.
• Strong troubleshooting experience
• Excellent communication skills to build strong cross functional relationships

We keep patients at the heart of everything we do and are committed to addressing some of the world's most challenging healthcare needs through scientific innovation and operational excellence.

As an equal opportunity employer, we value diversity and are committed to fostering an inclusive environment where talented and committed people can thrive and contribute their best work.

Required Skills:

• Analytical Assays
• Analytical Functions
• Analytical Method Transfer
• Analytical Testing
• Assay Development
• Laboratory Techniques
• Method Development
• Method Validation
• Technical Transfer

Employee Status:

Regular

Flexible Work Arrangements:

Hybrid

Job Posting End Date:

10/26/2026

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R421058