Posted: 16h ago
The role
Microbiologist – Technical Services/Manufacturing Sciences
The TS/MS microbiologist will ensure contamination control in the GMP production areas. They will support the microbiological, viral and environmental monitoring programs at the Limerick manufacturing site.
The successful candidate will provide technical support for the facility startup and beyond in partnership with engineering, operations, quality control and quality assurance. They will support up‑and down‑stream processing areas for activities including EMPQ and the preparation of strategy documentation such as contamination FMEA, response plans, product protection control strategy and investigations. The role requires deep technical expertise in microbiology, strong data‑driven decision‑making and problem‑solving capabilities, and a commitment to continuous process improvement with Digital Plant analytics and Process Analytical Technology.
Key Responsibilities
Have an in‑depth knowledge of the science of biotech manufacturing microbiological controls and associated analytical tests. Understand molecule‑specific control strategy and basis of specifications and critical quality attributes.
Work with the network and development organizations to ensure a well‑understood, robust and fit‑for‑purpose microbial control strategy is developed and transferred.
Possess knowledge of virology controls required for mammalian cell culture, virus and mycoplasma analytical methodologies.
Support the EMPQ program, contamination FMEA and contamination response plan.
Create, revise, or review documents such as SOPs, material specifications, protocols and trend reports (water, environmental monitoring, etc.) and perform investigations as needed.
Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and monitoring needs are captured in manufacturing electronic documentation.
Work as part of cross‑functional teams, establish partnerships with applicable functions, operations and TSMS Lab to understand the interface between the science/engineering with the operations on the floor and provide deep technical expertise to the team.
Identify process improvements and participate in implementation of Lean manufacturing initiatives.
Understand and ensure compliance with safety, compliance and regulatory expectations.
Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies.
Basic Requirements
Degree or Masters based in microbiology or a similar discipline.
Additional Requirements
Demonstrated technical capability with high productivity.
Proven track record of curiosity with learning agility.
Self‑starter with high initiative and a data‑driven approach to problem‑solving.
Demonstrated strong interpersonal skills.
Demonstrated strong verbal and written communication skills.
Demonstrated adaptability and flexibility for working in different environments, teams, etc.
Demonstrated ability to participate in and facilitate decision‑making.
Proficient in English.
Work Environment
These are 8‑hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities for all.
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.
#J-18808-Ljbffr
