Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences

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Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences

Apply locations Ireland, Limerick time type Full time posted on Posted 2 Days Ago job requisition id R-61705 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. Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences 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. T he TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will provide technical support for the facility startup defining microbial and viral control strategies in partnership with engineering, operations, quality control and quality assurance. The role will provide support to up- and downstream processing areas and will own activities such as EMPQ and preparation of strategy documentation including contamination FMEA and response plans and the product protection control strategy. The successful applicant will have a deep technical expertise in their areas of responsibility 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

• Establish and own 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.
• Understand basic statistical methodologies engage with Statisticians to assign specifications, validation acceptance criteria, material sampling criteria and analysis of batch data for summary reports and product reviews.
• 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

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

Basic Requirements:

• Hons Degree Qualified BSc, MSc, or PhD degree based in microbiology, biotechnology, biochemistry or similar discipline.
• Experience (>5 yrs) working in large molecule GMP manufacturing environment, operating in frontline microbiological support

Work Environment:

• These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. 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. #WeAreLilly

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