Senior QC Scientist

Senior QC Scientist

Regeneron

Limerick, Ireland

Job Description

Within this role you will perform assay transfers, validation and investigation activities for QC. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.

As a Senior QC Specialist a typical day might include, but is not limited to, the following:

• Performing assay validation for QC;
• Reviewing new test procedures and assays;
• Evaluating and bring in new methodologies, techniques, and equipment as needed;
• Generating and/or supporting the completion of compliance records, CAPAs, change controls and deviation notifications as needed;
• Evaluating assay performance through yearly method performance reports;
• Facilitating assay transfers from R&D and to business partners;
• Organising analytical assay transfer internally and externally;
• Performing additional studies supporting regulatory filing e.g. Bridging/comparability studies;
• Participating in technical troubleshooting and problem investigation;
• Reviewing analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance;
• Participating in training programs for analysts;
• Supporting and participate in regulatory inspections;
• Participating in cross-functional improvement initiatives/kaizens.

This role might be for you if

• You enjoy working in a fast-paced environment and you have the innate ability to balance multiple projects, prioritise them and complete them independently, while excelling at keeping all impacted parties well advised;
• You are able to work in a team environment but can also take ownership of large technical reports and projects;
• You can develop and drive scientific and/or business-related improvement ideas.

To be considered for this opportunity, candidates should hold a PhD in Microbiology, Chemistry, Biology, or a related field with 2+ years of experience, preferably in the pharmaceutical or biotechnology industries; an MSc with 7+ years of proven experience; or a BSc, which will be considered based on the candidate's years of experience and technical background, particularly within the pharmaceutical or biotechnology sectors.

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