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.

Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the technical capabilities to enable a successful startup of cGMP manufacturing operations.

Outline of Role:

The Specialist/Senior Specialist Microbiology analyst – QC role provides support to the start up and routine operations of the QC microbiology laboratory and works closely with the area technical lead and management. During start-up of the QC laboratories the role will be focused on developing E-systems, procedures and implementing test methods to support routine operations. This role will have oversight for the implementation and execution of the training programme for the QC microbiology analyst group. Furthermore, the role will focus on the implementation of data integrity requirements for microbiology laboratory equipment.

Key Responsibilities:

QC Testing

• Safety: Safety first approach to activities.
• Method verification: Author and execute method verification protocols for microbiological test methods such as bioburden and endotoxin.
• Study support: Provide support for microbiological studies through protocol and report authoring; study execution; data review and data analysis.
• Equipment SME: Serve as equipment SME for microbiology lab test equipment.

Compliance and Documentation:

• cGMP Compliance: Ensure all microbiological aspects of testing adhere to current Good Manufacturing Practices (cGMP). Ensure correct practices are in place in compliance with regulations, global standards and aligned with the site Data Management strategy.
• Data Review and Investigation: Lead microbiology laboratory investigations including alert and action limit excursions and deviations. Identify and implement corrective actions as needed.
• Documentation: Maintain accurate and detailed records. Author procedures, protocols, reports, investigations and change controls as required.
• Data integrity; Participate in data integrity assessments for area equipment and activities. Participate in and coordinate audit trail review process in collaboration with Quality Assurance/stakeholders.
• Inspection readiness: Support and participate in self-inspections or regulatory audits.

Training and Process Improvement:

• Training and Leadership: Develop training material and lead training for new analysts within the microbiology team in techniques such as bioburden, endotoxin, growth promotion, environmental monitoring, microbial identifications, TOC, conductivity etc.
• Process Enhancements: Proactively identify opportunities for process improvements in the laboratory and support implementation. Benchmark best practices for analytical technology and implement appropriate improvements.
• Collaboration: Provide technical support to lab analysts and operations as required.

Basic Qualifications/Requirements:

• Bachelor’s degree in Microbiology, Biology, or related field.
• Minimum of 2-3 years of experience in microbiology testing within a pharmaceutical or biotechnology environment.

Job specific pre-requisites:

• Deep technical expertise in QC microbiology techniques.
• Significant level of cross training and demonstrated training ability on multiple microbiological techniques (e.g., aseptic technique, bioburden, endotoxin, growth promotion, environmental monitoring, and microbial identification).
• Good understanding of data integrity in the QC laboratory
• Good understanding of regulatory requirements for micro testing Demonstrated excellent analytical technical, attention to detail and problem-solving skills.
• Demonstrated expertise in a variety of microbiological techniques.
• Demonstrated strong interpersonal skills.
• Demonstrated strong verbal and written communication skills.
• Demonstrated ability to participate in and facilitate decision-making.
• Good IT skills and knowledge of standard software packages (e.g. Microsoft Word, Excel) as well as laboratory-based software (e.g. LIMS systems, electronic lab notebooks etc..).
• Demonstrated good planning and organisational skills, ability to prioritise tasks, commitment to task completion and timelines.
• Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set.
• Coaching and mentoring capabilities
• Proficient in English.

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.

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.

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