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.

Organization Overview:

Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

Responsibilities:We are seeking a Associate/Senior Analytical Microbiologist to support our new Biologics Manufacturing Facility at Raheen Co. Limerick. The Associate/Senior Analytical Microbiologist role in the Quality Control area provides the analytical technical leadership for all aspects of microbiological technologies and methods.

This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and projects. The development, technical transfer and validation of the methods and their associated lifecycle will be a key aspect of this role.

The lifecycle management of existing technologies and instrumentation will be a further aspect of this role. This role will be responsible for all the information generated that will be used to support manufacturing objectives, across regulatory submissions and supply chain. The active participation in cross functional teams within the internal manufacturing sites and development will be required to understand manufacturing and regulatory requirements while also providing the analytical technical leadership and perspective to meet the manufacturing goals

Key Responsibilities:

The Associate/Senior Scientists key responsibilities shall include but shall not be limited to**:**

• Support the introduction, validation and on-going technical agenda for pipeline and commercial analytical methods and technology.
• Ensure methods are scientifically robust with the required performance attributes to satisfy stakeholder needs.
• Execute and/or oversee testing protocols in accordance with local procedure and regulatory requirements.
• Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
• Provide training and mentorship to QC team members and cross functionally.
• Act as SME for one or more technologies and / or business systems within QC. This will include the identification, sourcing, installation, and qualification of new equipment.
• Assure that all raw materials, utilities, including environmental, in-process samples or final products are appropriately analyzed and authorised. In the event of non-conformance to acceptable quality and/or safety standards, lead analytical investigations, using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are complete. Work with onsite technical teams to improve the state of validation and drive analytical variability reduction.
• Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients and Laboratory Periodic Review Reports (PRRs).
• Support and participate in self inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
• Proactively support management decisions and strategy and be a role model for Quality Control team members in terms of performance and behaviors.
• Influence the business/ external partners on critical issues to meet end goals – understand the external context/environment to achieve these goals.

Basic Requirements:

• BSc (Hons)/MSc/PhD Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 5 years pharmaceutical experience.
• Deep technical expertise in Microbiology techniques with emphasis on techniques to support various types of Microbiology testing (bioburden, Endotoxin)
• Highly Proficient in the use of multiple instrument platforms (e.g. plate reader, Molecular Devices, etc.) and software applications (e.g. LIMS / LES systems, etc).
• Excellent attention to detail in all aspects of the work.
• Detailed understanding of Data Integrity and its applications in a Digital Laboratory.

Additional Information:

• Deep technical expertise in analytical / biochemical / microbiological techniques, such as Endotoxin, Bioburden, rapid Bioburden techniques and Quantitative PCR.
• Proficiency in the use of multiple instrument platforms, such as automated microplate readers and microbiological identification systems and associated software applications.
• Highly competent with computer systems.
• Experience working in cross functional teams and proven ability in decision making.
• Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
• Strong organizational skills, including ability to follow assignments through to completion.
• Self-motivated, positive and ability to work under pressure.
• Demonstrates flexibility and adaptability to meet business needs.
• Excellent interpersonal and communication skills (written and oral).
• Demonstrates a continuous improvement mind-set.
• Demonstrated initiative – able to work proactively without direct supervision.
• Demonstrated ability to implement changes in technology and business systems / processes.

Other :

• Candidates must be able to travel for familiarization and training as required.
• May be required to work on a shift basis depending on production support needs.
• Candidates must meet the minimum qualifications outlined in the Educational Requirements section to be considered for the role.

Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation, and organizational skills.

Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to follow through on actions.  Is interested in own performance and seeks feedback to improve.

Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organization.

Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.

Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.

Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team.  Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.

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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