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.
Organization Overview:
The Senior Scientist Compliance role in Quality Control provides technical support for the compliance systems within the quality control laboratory. This role will be responsible for the interpretation of regulations; design, implementation, compliance and support of the laboratory quality systems associated with all testing activities within the QCL function.
Specifically, during the startup phase of the Limerick site (2024 to 2026) the senior scientist compliance will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function.
Responsibilities:
Job specific pre-requisites:
Safety first approach to activities.Proficient in English.Technical expertise in analytical equipment lifecycle management, compendial requirements for lab equipment and testing.Understanding of data integrity requirements in a QC environment.Highly competent in the use of digital solutions for data, equipment and laboratory management.Experience with regulatory inspectionsBasic Requirements:
Hons Degree Qualified – B.Sc. in Analytical Chemistry, Chemistry / Biochemistry, Microbiology, Molecular Biology, or related discipline, with a minimum of 5 years relevant GMP experience.
Additional Skills/Preferences:
Additional Information:
Candidates must be able to travel to US based locations for familiarisation and training as required. Duration and frequency will be dependent on experience levels and site goals.
Key Attributes (These will be what are used to assess the candidates):
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 organisational 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 take act. 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 organisation.
Ability to lead people: 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.
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