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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 Eli Lilly and Company, we unite caring with discovery to create medicines that make life better for people around the world. Our Central Technical Service Manufacturing Science (TSMS) group is committed to manufacturing science and embracing technologies, partnering with broad Manufacturing Organizations to accelerate launches, increase manufacturing capacity and resilience, and reach more patients faster. This Manufacturing Science and Process Innovation role in Central TSMS focuses on embracing cutting-edge technologies and process innovation to advance our manufacturing processes for peptide drug substance. This significantly contributes to continued improvement in increasing manufacturing capacity and supply resilience, reaching more patients faster with our increase product portfolio.

We are seeking a highly motivated, experienced, and agile process development Scientist/Engineer to join our Central TSMS team. The ideal candidate will play a pivotal role in driving process innovation and enhancing manufacturing science for peptide drug substance production and the exciting portfolio demands. This is a great opportunity to work collaboratively with cross-functional teams to evaluate and adopt new technologies to improve process efficiency, ensure product quality, advance our manufacturing capabilities, and make an impact to patients we serve.

Key Responsibilities:

Manufacturing Science Expertise:

+ Technical expertise with deep knowledge of the processes to be implemented for peptide commercialization. Provide excellent technical support for successful tech transfer, implementation in plant sites, robust production, and problem-solving for process-related operation issues.

+ Maintain a thorough understanding of the state-of-the-art manufacturing and regulatory requirements, process innovation, and the latest advancements in peptide manufacturing and incorporate these into technical agendas for Post Launch Optimization (PLO) and advancing manufacturing capabilities.

+ Demonstrate learning agility and flexibility to quickly pivot and learn new technologies, andsuccessfully support an expanding product portfolio beyond peptideswiththe increased complexity and their manufacturing processes.

Process Development & Innovation:

+ Lead TSMS technical projects eitherexternally through technical oversightto business partners or internally (experimental design, process development, modeling/production data analysis) to ensure a robust execution of post-launch technical projects and its delivery; fully understand business needs, anddevelop critical technical agenda and ensure its delivery.

+ Actas the process/ platform technical steward for all accountable products.

+ Identify and evaluate process improvements to enhance efficiency, scalability, and quality in peptide production.

Collaboration** **and** **Regulatory Compliance** **:

+ Engage strongly with PRD on new products, processes, and platforms to ensure successful and streamline implementation of new processes.

+ Collaborate with cross-functional teams, including Product Research and Development, quality assurance, and regulatory affairs, to enable the commercialization of the product and PLO technical agenda delivery and process change implementation.

+ Ensure compliance with regulatory standards and internal policies related to process development and manufacturing.

+ Prepare and review documentation for regulatory submissions and manufacturing protocols.

Qualifications / Basic Requirements:

+ Ph.D. or Master’s degree in Chemical Engineering, Biotechnology, Chemistry/Biochemistry, Pharmaceutical Sciences, or a related field.

+ Minimum 3 years industry experience in process development and innovation within a product/process development or manufacturing environment.

Additional** **Skills** **/ Preferences** **:

+ Familiarity with cGMP regulations and quality management systems.

+ Proficiency in analytical techniques relevant to peptide characterization and process optimization (HPLC, MS, etc.).

+ Excellent problem-solving skills and ability to work under pressure in a fast-paced environment.

+ Strong interpersonal and communication skills, with the ability to work collaboratively across teams.

Other Information:

The role will support various products and their production sites in various locations (US and OUS). Travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible.

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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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

$123,750 - $198,000

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.

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