Sr. Manager - Bioanalytical Laboratory

at  Lilly

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. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a brand-new manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically sophisticated manufacturing sites and will include next-gen manufacturing technologies, and sophisticated data collection and analysis platforms that will result in safety and quality improvements, increased efficiency, and variability reduction.
We are currently seeking a talented individual to fill an opening for a Senior Manager position in the Bioanalytical Laboratory within the Quality Control Laboratory team at Eli Lilly Limerick. This position is a permanent role based at our new Biologics Manufacturing Facility at Raheen, Co. Limerick!

BASIC QUALIFICATIONS/REQUIREMENTS:

• You have a BSc, MSc or PhD in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 3-5 years cGMP pharmaceutical / Biotechnology supervisory experience.

ADDITIONAL SKILLS/PREFERENCES:

• Demonstratable knowledge of cGMPs and other regulations related to pharmaceutical laboratory operations with an emphasis on analytical techniques such as immunoassays, quantitative PCR, chromatography, capillary electrophoresis and spectroscopy.
• Proven understanding of Data Integrity and its application in a Digital Laboratory.

RESPONSIBILITIES:

A typical day for a Senior Manager in the Bioanalytical Laboratory might include, but is not limited to, the following:

• Provides leadership, direction, and oversight of the Bioanalytical team to meet customer goals such as analytical approval cycle time, compliance and regulatory support, and improvement of lab quality systems.
• Establishment of yearly objectives, metrics to measure success; leading staff toward achieving strategy and goals.
• Help build and retain a phenomenal team for the QCL lab!
• Working with your team to develop & maintain their training, performance management plans, reviews & career plans; provides performance management (PM) feedback.
• Responsible for review of specific quality documents consistent with procedure requirements.
• Responsible for ensuring that Bioanalytical team meet customer goals such as analytical approval cycle time, compliance and regulatory support, and improvement of lab quality systems.
• Design / Build / Maintain QCL digital systems in collaboration with the site and external Digital teams.