Microbiologist - technical services/manufacturing sciences

Lilly allie le soin à la découverte pour améliorer la vie des gens partout dans le monde. Lilly est un chef de file mondial des soins de santé, avec son siège à Indianapolis. Nos collaborateurs travaillent à découvrir et à fournir à ceux qui en ont besoin des médicaments qui transforment la vie, à améliorer la compréhension et la gestion des maladies et à redonner à nos communautés grâce à la philanthropie et au bénévolat. Nous donnons le meilleur de nous-mêmes à notre travail, et nous accordons la priorité aux personnes. Nous recherchons des collaborateurs déterminés à améliorer la vie des gens dans le monde entier.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Owing to the continuous growth of our Monoclonal pipeline of products, Eli Lilly & Company has invested in a new facility in Ireland, Lilly Limerick. To support this exciting new investment and meet the requirements of a safe and successful start-up, we are eager for talented individuals to join our team(s) and contribute to establishing Lilly Limerick as a reliable supplier of our innovative medicines and our goal of making a difference to people’s lives.

If you are looking for a challenging, rewarding career and feel you meet the requirements listed below we would love to consider you for a role at Lilly, Limerick.

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. The role will provide support to up- and downstream processing areas for activities including EMPQ and preparation of strategy documentation including contamination FMEA, response plans, the product protection control strategy and investigations. The successful applicant will have a deep technical expertise in microbiology and demonstrate strong data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process efficiency by implementing new technologies and process improvements. They will maximize the benefits of a Digital Plant to gain in depth knowledge of the process through data 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
* Knowledge of virology controls required for mammalian cell culture, virus and mycoplasma analytical methodologies
* Support the EMPQ program, contamination FMEA and contamination response plan
* Creates, revises, or reviews documents such as: SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, etc) and performs 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, and establish partnerships with applicable functions, operations and TSMS Lab to understand interface between the science/engineering with the operations on the floor and bring 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 similar discipline.

Additional Requirements:

* Demonstrated technical capability with high productivity
* Proven track record of curiosity with learning agility
* Self-starter with high initiative and data-driven approach to problem-solving
* Demonstrated strong interpersonal skills
* Demonstrated strong verbal and written communication skills
* Demonstrated adaptability and flexibility to 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.

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