At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.
Job Description
Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland.
Role Overview
The Senior Principal Scientist (Bioanalytical) role in Quality Control provides analytical leadership for all aspects of bioanalytical technologies and methods.
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, analysed 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.
Leadership/Site Management:
* Proactively support management decisions and strategy.
* Be a role model and mentor for Quality Control team members in terms of performance and behaviours.
* Influence business/external partners on critical issues to meet end goals – understand the external context/environment to achieve these goals.
* Attend and contribute to relevant internal and external technical fora.
Candidates must be able to travel to US based locations for familiarisation and training. Duration and frequency will be dependent on experience levels and site goals.
Educational/Experience Requirements:
* BSc/MSc/PhD in Biochemistry, Molecular Biology, Cellular Biology, Biology or related field with minimum 7 years of recent experience preferably in a QC laboratory environment.
* Experience with molecular testing, such as ELISA assays, qPCR assays.
* Experience with separation testing, such as HPLC, UPLC, CE, iCIEF assays.
We are an equal opportunities employer and welcome applications from diverse candidates. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.