We are building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland, and need a Senior Manager for the Bioanalytical Laboratory within the Quality Control Laboratory team. The role is permanent and based at our new Biologics Manufacturing Facility in Raheen, Co. Limerick.
Responsibilities
Provide 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.
Establish yearly objectives and metrics to measure success; lead staff toward achieving strategy and goals.
Help build and retain a high‑performing team for the QCL lab.
Work with your team to develop and maintain training, performance management plans, reviews and career plans; provide performance management feedback.
Review specific quality documents in line with procedure requirements.
Ensure the Bioanalytical team meets customer goals such as analytical approval cycle time, compliance and regulatory support, and improvement of lab quality systems.
Design, build and maintain QCL digital systems in collaboration with the site and external Digital teams.
Basic Qualifications / Requirements
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
Demonstrable 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.
Additional Information
Some travel to other sites for training may occur, but this will be rare.
May be required to work on a shift basis depending on production support needs.
Benefits
Employee Assistance Programme
Gym and wellbeing spaces
Educational assistance
Long service awards for 5+ years of service
Above‑minimum holiday allowance (with bank holidays on top)
Company sick pay
On‑site parking
Bonus
Corporate Social Responsibility events
Subsidized canteen
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.
If you require accommodation, please contact us.
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