Senior/Principal Microbiologist

Eli Lilly Benelux Limerick, Ireland

Responsibilities:

We are seeking a Senior/Principal Analytical Microbiologist to support our new Biologics Manufacturing Facility at Raheen Co. Limerick. The Senior/Principal Analytical Microbiologist role in the Quality Control area provides the analytical technical leadership for all aspects of microbiological technologies and methods.

This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and projects. The development, technical transfer and validation of the methods and their associated lifecycle will be a key aspect of this role.

The lifecycle management of existing technologies and instrumentation will be a further aspect of this role. This role will be responsible for all the information generated that will be used to support manufacturing objectives, across regulatory submissions and supply chain. The active participation in cross functional teams within the internal manufacturing sites and development will be required to understand manufacturing and regulatory requirements while also providing the analytical technical leadership and perspective to meet the manufacturing goals

• Support the introduction, validation and on-going technical agenda for pipeline and commercial analytical methods and technology.
• Ensure methods are scientifically robust with the required performance attributes to satisfy stakeholder needs.
• Execute and/or oversee testing protocols in accordance with local procedure and regulatory requirements.
• Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
• Provide training and mentorship to QC team members and cross functionally.
• Act as SME for one or more technologies and/or business systems within QC. This will include the identification, sourcing, installation, and qualification of new equipment.
• Assure that all raw materials, utilities, including environmental, in-process samples or final products are appropriately analyzed and authorised. In the event of non-conformance to acceptable quality and/or safety standards, lead analytical investigations, using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are complete. Work with onsite technical teams to improve the state of validation and drive analytical variability reduction.
• Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients 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, Food and Drug Administration, etc.
• Proactively support management decisions and strategy and be a role model for Quality Control team members in terms of performance and behaviors.
• Influence the business/external partners on critical issues to meet end goals – understand the external context/environment to achieve these goals.

Basic Requirements:

• BSc (Hons)/MSc/PhD Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 5 years pharmaceutical experience.