Senior Principal Scientist/Advisor, MES – Lebanon API Manufacturing Full-time

Senior Principal Scientist/Advisor, MES

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 an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). 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 greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Position Description

The Senior Principal Scientist/Advisor, MES will support implementation of manufacturing batch records and associated IT Systems for Lilly's implementation of a next gen MES (Manufacturing Execution System – electronic batch record), representing TS/MS (Technical Services) as a business SME. Lilly is at a critical juncture as we tool up to realize the potential of our product pipeline. We are building new processing capabilities around the world which include an emphasis on emerging, cutting-edge processing technologies such as continuous processing and advanced biotech platforms. This includes the new Lilly Lebanon API facility which is being built as a state of the art, digitally native plant. Lilly places a high value on fully automated manufacturing processes, as the quality and operational benefits are baseline expectations of new process design.

This role is a senior-level scientific role which requires a minimum 4-year science/engineering degree, preferably with significant product/process experience, and mastery of MES systems. The position requires high learning agility and a solid technical background to deploy product control strategies, operational control strategies, and data integrity across this new MES platform. The primary focus of the role will be a liaison for TS/MS with the MES team to deploy the new MES platform within the Lilly Lebanon API site.

Key Objectives/Deliverables

The Senior Principal Scientist/Advisor, MES will represent the TS/MS function in the Lilly Lebanon API facility start up, ensuring integration with our manufacturing processes and product requirements.

• Design and deliver MES production instructions and transition to support of routine manufacturing operations.
• Serve as the TS/MS subject matter expert for MES functions and provide technical leadership to the Lilly Lebanon API team related to process and batch record requirements for drug substance manufacturing.
• Translate product control strategy and process flow document requirements into accurate instruction sets to support building MES requirements.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.
• Guide the change prioritization process for MES, working with the business to understand change requirements and collaborating with IT to understand complexity.
• Participate in design reviews, final design specification reviews, and localization of API manufacturing batch records.
• Provide MES technical support both for the initial start-up of the manufacturing areas as well as post Process Validation support.

Manufacturing Execution System (MES) Expertise

• High level of expertise in both product/process knowledge and integration with MES systems.
• Ability to maintain technical interactions in a cross functional team across IT, Operations, Engineering, and Technical Services.
• Able to serve as the lead for day to day decision making for the TS/MS MES function.
• Able to influence teams and build understanding of MES functions across site.
• SME for TS/MS function on the system capabilities and MES escalation point for TS/MS function.
• Identify areas of standardization and develop harmonized processes where appropriate.
• Act as an ambassador for the program and advocate for TS/MS.
• Act as consultants to the deployment teams.

Basic Requirements

• Minimum Bachelor of Science Degree in science or engineering discipline
• 7+ years experience including 4 years GMP experience
• Demonstrated history of working across global teams in the MES space.
• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities.
• Strong knowledge of pharmaceutical manufacturing processes, facility start-up procedures, and GMP regulations.

Preferences

• Prefer 10+ years of progressively responsible experience in pharmaceutical manufacturing support role such as Technical Services/Manufacturing Sciences.
• Experience supporting cGMP manufacturing (specifically within Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance, etc.)
• Data Integrity – Partner to develop robust and innovative solutions enabling data integrity.
• Process Monitoring – Collaborate with Automation, QA, and Operations to develop advanced analytics solutions which identify process issues and drive improvement decisions.
• Strong analytical and quantitative problem-solving skills.
• Experience in statistics.
• External and innovation focus, combined with a strong understanding of business objectives, manufacturing /quality processes and technologies, to define the future state for manufacturing.
• Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.

Additional Information

• This is a fully on-site position located in Lebanon, IN
• Travel to other Lilly domestic and international locations generally not exceeding 10%
• This position is day shift, Monday-Friday, with off-hours support needed, by request

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 $64,500 – $167,200. 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.