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.
Analytical Scientist Expert in Method Standardization, AQCO
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 entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to create new state-of-the-art manufacturing site's and continue expanding our existing facilities to created capacity required to continue with our mission. The brand-new facilities will utilize the latest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.
Come help us transform Lilly's Analytical landscape with LEADS (Lab Excellence - Accelerate, Digitize, Standardize).
Lilly has initiated a multi-year Digital Quality Labs transformation program that will simplify and implement a Digital Lab agenda at Lilly. This is part of a broader set of enterprise-wide programs focused on enabling unprecedented company growth and delivery of new modalities serving patients around the world.
What You'll Be Doing as Analytical Scientist Expert in Method Standardization
As part of the LUNA rollout, analytical method standardization will be a key enabler to ensure the Accelerated deployment of the program. To drive and support this effort, we will be filling several analytical SME positions within the Acceleration Team. These SMEs will have specific technical capabilities across a range of Analytical Techniques (including Chromatography, Microbiology, API, Dry Drug Product, Parenteral Drug Product and Device) and will work closely with the Analytical Stewards, site SMEs and the LUNA team. We will also be looking for one standardization SME with expertise in Lab Informatics, specifically LabVantage (with Empower or MODA as an additional benefit).
- Your primary role is to assist in developing, documenting, and deploying standardized QC analytical test methods.
- Help to accelerate standardization of those methods most impacted by the deployment of the global LUNA program.
- Develop 'golden' method templates for methods within their own area of expertise.
- Compare current methods across the sites to identify differences and recommendations for best practices, including external benchmarking and use of different tools and technologies (e.g. Artificial Intelligence).
- Apply your technical knowledge to help drive decisions in method standardization workshops with Method Stewards and other Global SME partners.
- Write the technical justification to support global method change controls and support the steward in networking these changes.
- Deliver to integrated schedules and priorities globally partnering with sites and central organization.
- Ensure robust communication strategies to facilitate success of the program.
- Identify barriers to implementation; develops and owns solutions to address issues as they occur.
How You'll Succeed
- Be Bold - We are looking for an expert who will tackle tough challenges and coach through translation of complex business requirements into robust business process and data solutions.
- Be Fast - We need someone who will move at the pace of MQ and the Growth of the organization.
- Be Engaging - We need a scientist who will engage with colleagues and who will focus on re-imagining Quality and Manufacturing processes using automated solutions and new capabilities such as Artificial Intelligence.
Experiences and Knowledge You'll Require
- Demonstrate a combination of technical and soft skills to effectively collaborate with cross-functional teams and drive continuous improvement with Quality Lab processes.
- Proactively monitor and stay abreast of evolving business and technology trends, in the realm of Digital Quality Labs in Manufacturing. Continuously seek out innovative approaches to enhance our processes.
- Have experience with cGMP regulations and Data Integrity requirements in a highly regulated environment.
- Demonstrate a strong understanding of QC business processes, QC equipment and Instruments.
- Leverage an agile mindset and framework for the entire lifecycle.
Your Basic Qualifications
- Bachelor's degree (or equivalent) in scientific/engineering discipline.
- 5+ years of relevant GMP experience and technical proficiency as an analytical scientist in a QC laboratory.
Additional Preferences
- Understanding of IT systems, in particular. Empower, MODA and LabVantage.
- Relevant Cross-functional Assignments, leading projects and leading change.
- Excel in negotiation, driving consensus across complex stakeholder groups to achieve desired business outcomes. Combine assertiveness with effective change management.
- Passion for working on a team from diverse backgrounds and geographies.
- Thorough knowledge of cGMPs and Quality systems with demonstrated technical proficiency.
- Ability to function in a team environment.
- Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
- Ability to effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audience types.
- Demonstrated ability to lead change and influence at a site/network/corporate level.
Other Information:
- The normal schedule for this position is Monday-Friday, 8 hours/day.
- Global travel is required with this position to support global sites and for participating in workshops.
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
- This role can be based out of Indianapolis, IN or any of our US manufacturing sites
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 ( ) 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$76,500 - $162,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.