Associate Scientist Full-time

Associate Scientist

A fantastic opportunity has arisen for an Associate Scientist to support the Dundalk QC team. The role sits within the Site Analytical Sciences organization, part of Global Quality, Large Molecule Analytical Sciences.

You will contribute to release and stability testing in a fast-growing, dynamic start-up environment, working with cutting-edge technology. The role also includes method execution and troubleshooting, transfer and verification of new methods, support for Digital Lab Records, and involvement in continuous improvement and compliance activities within a regulated QC environment.

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

• Review and evaluate analytical data.
• Support the digitalization program, including method review for Digital Lab Records implementation and requalification of equipment.
• Support qualification of equipment.
• Support technology transfers from other sites.
• Take GMP requirements into account when setting up experiments and protocols.
• Ensure compliance of protocols and reports.
• Ensure safety at a lab level.

What skills you will need:

In order to excel in this role, you will more than likely have:

Required

• Minimum a Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences or a related scientific discipline.
• Proven experience in the pharmaceutical industry.
• Hands-on experience with compendial methods (pH, TOC, KF, Appearance, Osmolality), Total Protein, EIAs, PCR or micro methods.
• Understanding of the product development trajectory.
• Understanding of regulatory filing requirements (IND, IMPD, MAA, BLA).
• Understanding of existing regulatory GMP requirements (ICH, pharmacopeia).

Preferred

• A proven pro-active, service-oriented and communicative mindset
• Ability to troubleshoot and work independently
• High personal integrity, credibility, and energy
• Passion for Lean and Continuous Improvement

Our Companies in Ireland is one of the country's leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. We work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products – strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

Required Skills: Analytical Chemistry, Biochemistry, Conducting Experiments, Data Analysis, Drug Product Development, GMP Compliance, Laboratory Techniques, Pharmaceutical Sciences, Technical Problem-Solving

Preferred Skills: