Senior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences
Eli Lilly
- Limerick
- Permanent
- Full-time
- 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
- 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
- Hons Degree Qualified BSc, MSc, or PhD degree based in microbiology, biotechnology, biochemistry or similar discipline.
- Experience (
- These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.