Microbiologist - Technical Services/Manufacturing Sciences

Eli Lilly and Company; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

Lilly Ireland, Monoclonal pipeline growth, seeks a microbiologist to support GMP production areas with contamination control and environmental monitoring. The role partners with engineering, operations, QC and QA to enable start-up and steady-state manufacturing.

We value deep microbiology expertise, data-driven decision making, problem solving and strong communication. 8-hour shifts with occasional evenings/weekends; English required; disability accommodation available.

Qualifications

• Deep knowledge of biotech microbiology controls and analytics.
• Experience with environmental monitoring programs and QC/QA interfaces.
• Familiarity with GMP and regulatory expectations.

Responsibilities

• Deep knowledge of biotech microbiology controls and analytics.
• Collaborate with network and development teams on microbial control strategy.
• Virology controls for mammalian cultures, virus and mycoplasma assays.
• Support EMPQ program, contamination FMEA, response plans.
• Prepare and review SOPs, specs, protocols, trend reports; conduct investigations.
• Link process parameters with MES/eBR to meet regulatory and monitoring needs.
• Collaborate with cross-functional teams to align science and operations.
• Identify process improvements; participate in Lean initiatives.
• Ensure safety and regulatory compliance.
• Assist regulatory submissions and responses.

Skills

Microbiology

Environmental monitoring

GMP compliance

Data analysis

Communication skills

Problem solving

Team collaboration

English proficient

Education

Bachelor's/Master's in Microbiology

Job description

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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes 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.

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