Senior Principal Research Scientist

2 days ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time
Job Overview

Eli Lilly and Company is a global pharmaceutical leader committed to delivering innovative solutions for complex health challenges. We seek a highly skilled Senior Principal Scientist to join our team in Limerick, Ireland. This individual will lead the introduction, validation, and on-going technical agenda for pipeline and commercial analytical methods and technology.

About the Role

As a Senior Principal Scientist, you will be responsible for developing and validating robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs. You will also execute and/or oversee testing protocols in accordance with biosafety, local procedure, and regulatory requirements. Additionally, you will develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.

Key Responsibilities

* Lead the introduction, validation, and on-going technical agenda for pipeline and commercial analytical methods and technology
* Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs
* Execute and/or oversee testing protocols in accordance with biosafety, local procedure, and regulatory requirements
* Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions
* Develop strong links with Bioproducts Research and Development and participate in the development and transfer of new techniques and methodologies
* Develop strong links with other manufacturing sites to deliver their support needs
* As required provide training or mentorship to other QC or cross-functional team members
* Act as SME for molecular and chromatographic based analytical technologies. This may include the identification, sourcing, installation, and qualification of new equipment
* Assure that all samples are appropriately received, stored, analyzed, and disposed of appropriately. This also includes testing outsourced to third parties
* In the event of non-conformance to acceptable quality and/or safety standards, lead, and document analytical investigations using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are appropriately implemented
* Keep abreast of relevant scientific literature, new technologies/capabilities, and regulatory initiatives/requirements and support their implementation, as appropriate
* Support the writing of Annual Product Reviews (APRs) and Laboratory Periodic Review Reports (PRRs)
* Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, and Food and Drug Administration

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