Lilly Analytical Technical Steward - API External Manufacturing - QC in Kinsale, Ireland
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 39,000 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.
An Analytical Technical Steward in the API External Manufacturing Quality Control Laboratory is a technical position helping to ensure that the analytical testing of products at multiple contract manufacturing (CM) sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The position is fast-paced, with multiple activities occurring simultaneously at potentially multiple CM sites. The Analytical Technical Steward reviews data released by the contract manufacturer to ensure it meets expectations, reviews deviations for trends, reviews and/or releases stability data and leads the resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional post-launch process optimization teams. The Analytical Technical Steward works closely with development to ensure robust analytical control strategies are established in QC for the molecules they support.
Technical review, interpretation, and release of data including release data from CM, stability, process validation, and reference standard characterization.
Utilizes technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Guides CMs to perform root cause analysis investigations and develop solutions to prevent reoccurrence.
Develop investigational testing protocols and perform testing as required.
Contribute to annual product review and process validation as required.
Communicate effectively in both written and oral formats within the lab as well as with CMs and business partners.
Participates in internal/external audits as needed
Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
Method assessments, deficiencies and areas for improvement noted within the assessments.
Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed.
Method validations (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in laboratory practices).
Review of analytical test method packages
Approval of test method protocols
Approval of new test methods or changes or deletions to existing test methods
Provide laboratory support (e.g., method development, validation and Method development work and implementation of method improvements for marketed products (including: laboratory work, training/transfer of new method to CM labs, change controls, and regulatory submissions).
Implement new technologies into the CM Labs and improve existing methodologies.
Improve assays in the CM Labs. These improvements include variability reduction, method optimization, and new method development.
Local and Global Method Change Control Ownership
Oversight over reference standard evaluations
Selection of appropriate packaging materials
Participate in the review of the reference standard profile and associated documentation for data integrity
Consult in the preparation of the characterization protocol for corporate reference standards
Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards
Method transfers between QC labs and to CMs
Oversee transfer of analytical methods for marketed products to CMs or other QC Labs.
Monograph review and implementation
Ensure consistent practices between global laboratories.
Effective management of multiple projects.
Demonstrate proficiency in complex laboratory analysis in a cGMP laboratory, including, but not limited to chromatographic, spectroscopic, and/or microbiological assays.
5+ years’ experience supporting analytical aspects of monoclonal antibody clinical trial development and/or manufacturing
Strong skills in making risk-based decisions and prioritization
Deep understanding of cGMP compliance requirements and regulatory expectations
Demonstrated accuracy and proficiency in analytical skills
Demonstrated strong problem-solving skills.
Strong oral and written communication skills and demonstrated through documentation and presentation skills
Demonstrated strong interpersonal interaction skills
Demonstrated experience with method qualification and validation
Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations.
Previous experience working with contract laboratories in a cGMP environment
Training and demonstrated proficiency in root cause analysis methodology
Bachelor degree (4 year university) in a science field related to the lab (e.g. Chemistry, Biochemistry, Biology)
Must complete applicable Learning Plan
May be required to provide 24 hour cell phone coverage
May require up to approximately 20% of international travel
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 39,000 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. #WeAreLilly
Lilly is an EEO/Affirmative Action Employer and 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.
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!