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.
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:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a Lebanon manufacturing site, and the successful candidate will help to build the overall site readiness plan to enable a successful startup into GMP manufacturing operations.
Responsibilities:
The Site Analytical Steward provides analytical technical support for commercialization and routine support of the Lebanon Plant Site 1 for all analytical technologies in support of the product control strategy and regulatory submissions. The Site Analytical Steward utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff and sharing technical information and best practice within the work group and across plant sites. The Site Analytical Steward participates and influences the technical agenda of the plant or corporation.
The Site Analytical Steward reviews, interprets, and releases batch results for the laboratory. When appropriately qualified, performs the holistic review of analytical results associated with a batch and issues the Certificate of Testing (CoT), when required. The Site Analytical steward leads analytical investigations/forensics, the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. They may perform non-routine lab work in support of those projects for resolution of these analytical technical issues, sample characterization, or method development, transfers, and validation. They coordinate with the QC labs in the commercialization of new products to the site for analytical methods.
The Site Analytical Steward works closely with the TS/MS Molecule Steward, process teams, and overall organization and influences the technical agenda.
Key Objectives/Deliverables:
Comprehensive Technical Review
- When Certificate of Testing (CoT) is required, perform in-depth technical review and release of individual test data prior to CoT issuance for the associated batch.
Certificate of Testing (CoT) Issuance
- For release testing of manufactured API batches, re-evaluated API, and stability test results, as well as reference standard characterization packages, an appropriately qualified technical resource performs a holistic technical assessment of all analytical testing associated with the batch prior to issuing a CoT.
Production and Investigation Support
- Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
- Troubleshoot equipment and methods as required.
- Develop investigational testing protocols and perform testing as required.
- Interacts effectively with business partners to communicate, resolve issues, and gain a clear, accurate understanding of each other's requirements.
Continuous Improvement Initiatives
- Share technical information and authors regulatory and/or technical reports and memos.
- Research and recommend new technologies.
Training and Mentoring
- Perform technical training as needed.
- Provide coaching and mentoring to Quality Control Laboratory personnel (e.g., technical issues, root cause analysis, and investigation techniques).
- Provide strategic and tactical support to drive technical training into Quality Control Laboratory operations.
Deviations and Change Controls
- Review and approve change controls and observations/deviations.
- Review, interpret data, document results of analyses, conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Writes and publishes regulatory and/or technical reports and memos.
Business Support
- Support management in insuring that all laboratory operations are in compliance with the applicable procedures and standards.
- Provide leadership for the development, improvement, implementation and execution of lab quality systems; develop content, review and approve SOPs and training as necessary.
- Contribute to development and implementation of Global Quality Standards for laboratories.
- Comply with safety standards and ensure safety programs are maintained for the laboratory.
- Ensure interpretation of results for process monitoring are performed and provide technical oversight.
- Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners.
- Review and approve protocol-driven studies (e.g., method validations, investigational studies and method transfers).
- Provide quality and timely customer service.
- Develop and ensure execution of quality plan projects.
- Define and monitor productivity and continuous improvement opportunities.
- Execute notification to management when required by procedures or standards.
- Assist in business plan development and execution.
- Contribute to APR and process validations as required.
Inspection Support
- Define and maintain inspection readiness activities.
- Interact with regulatory agencies during GMP inspections as appropriate.
Method Stewardship/Benchwork
- Authors or contributes to Site Analytical Transfer Strategies.
- Method development and validation/remediation.
- Evaluate new technologies.
- Monitor method and process performance.
Basic Requirements:
- Bachelor's degree (4-year College) in a science field related to the lab (e.g., chemistry, micro or biology)
- 7+ Years of QC or Analytical Development Experience with small molecules, peptides, oligonucleotides or proteins
Additional Preferences:
- Preferred training and demonstrated proficiency in Root Cause Analysis methodology.
- Experience in the development and validation of analytical technologies.
- Experience and knowledge of cGMP requirements in drug substance manufacturing.
- Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, and/or microbiological assays.
- Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations.
- Deep understanding of compliance requirements and regulatory expectations.
- Demonstrated accuracy and proficiency in analytical skills.
- Demonstrated strong problem-solving and analytical thinking skills.
- Ability to focus on continuous improvement.
- Demonstrated leadership skills (good interpersonal communication skills, decision making, prioritization, mentoring, problem solving, conflict resolution).
- Proficiency with computer systems.
- Understanding of statistical tools and analysis.
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 ( ) 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.
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