Scientist Full-time

Scientist

The Technical Services team is seeking an experienced Scientist to support the commercial production of Drug Substance batches from the suite 1 and suite 2 manufacturing facilities.

The successful candidate will work collaboratively with the broader Technical Services Teams to provide technical services that align with site business objectives. The role involves transitioning efficiently between projects and/or managing multiple smaller projects at the same time. This position reports to the Technical Services manager for the suite 1 and suite 2 sustaining team and is part of the site technical services group.

Job Responsibilities include but are not limited to:

• Supporting the Operational Unit to ensure alignment with the plan of record. This encompasses supporting investigations, enhancing process robustness, and driving projects focused on process and yield improvements.
• The review, assessment and approval of supplier change notifications (SCNs). Responsibilities may include preparing, reviewing, and executing protocols, as well as authoring supporting documentation for changes resulting from the SCNs.
• Supporting the introduction of new or alternate raw materials or consumables.
• Authoring/ reviewing sections of regulatory dossiers including health authority query responses
• Authoring/reviewing the annual continued verification reports for the product in the manufacturing in suite 1&2.
• Authoring / reviewing specific sections of the Annual product review report.
• Supporting regulatory inspections.
• Developing and maintaining effective working relationships with other departments such as Operations, QA, QC, QPs, regulatory, supply chain and MSAT as well global teams.

Education and skills:

• Third level qualification in Science, Engineering or equivalent.
• Minimum of 3 Years cGMP industrial experience within bioprocess manufacturing sector.
• Strong knowledge of downstream drug substance manufacturing preferred
• High technical capability for interpret complex data, problem solving and technical learning

• Strong technical writing skills a must.
• Capability of working in a multi-disciplinary team environment to tight timelines

• Effective communication, planning and organisation skills to deliver documentation on time.

Work Location Assignment: Hybrid

In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland. Please note there is no relocation support available for this position.

Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!