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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.

Job Position Overview:

The TSMS Local Site Molecular Steward serves as the technical representative for the Lebanon facility. This role collaborates with central TSMS teams and other manufacturing sites to ensure robust molecule stewardship, seamless transfer of API from pre-commercial to commercial stages, and commercialization support for new molecules.

This position requires comprehensive knowledge of the pharmaceutical industry, current Good Manufacturing Practices (cGMP), regulatory requirements, and advanced process chemistry. The successful candidate should have a proven track record of driving technical and manufacturing agendas. The role involves cross-functional collaboration within the site, across the network, and with commercialization teams and other functions.

Responsibilities:

+ Provide technical oversight and stewardship for one or more molecules manufactured at the Lebanon facility. Lead technical transfer of processes between production facilities. Anticipate and address complex scale-up issues.

+ Facilitate process knowledge transfer to Process Team members. Assist in process-related training for Manufacturing Process Team members.

+ Collaborate with Manufacturing to support the start-up and qualification of new facilities and associated process equipment. Help define and implement control strategies for Lilly Lebanon processes.

+ Author, review, or approve standard operating procedures related to TS/MS activities. Review and approve manufacturing batch records and other documentation.

+ Author, review, or approve technical documents supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies. Review and approve Annual Product Review and present annual Global Product Assessment for stewarded molecule(s).

+ Serve as a technical leader supporting API manufacturing. Lead the resolution of technical issues, including those related to control strategy and manufacturing.

+ Anticipate and resolve key technical or operational problems, communicate issues promptly, and lead process-related investigations. Assess technical impact and influence complex regulatory or technical issues within the TS/MS. Encourage adoption of new perspectives on challenging concepts.

+ Mentor and provide scientific expertise to Process Team members. Apply process knowledge and data analysis skills to support the API manufacturing operations. Drive solutions that impact results across sites or functions.

+ As required, design laboratory experiments to guide process troubleshooting and continuous process improvement. Help define and implement medium to large continuous improvements to manufacturing processes.

+ Lead post launch technical agendas and deliver projects that drive substantial step changes in manufacturing.

+ Interact with regulators or other stakeholders on technical issues or in support of internal and external agency audits.

+ As required, may lead or assist in the planning and execution of process validation activities.

+ As required, may own or assist in the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity.

+ Make decisions that impact a function or geography. Build relationships with internal and external partners.

+ Understand and perform all job responsibilities in compliance with quality, safety and regulatory expectations as well as cGMP.

Basic Requirements:

+ **Education Level** : Bachelor’s degree in Chemistry, Engineering, Pharmaceutical Sciences, or a related field (Chemistry focus preferred).

+ **Experience:** Minimum of 7 years of direct experience in cGMP API manufacturing, covering multiple unit operations and platforms related to API development, commercialization, and commercial production.

Additional Skills/Preferences:

+ Strong technical leadership and communication skills.

+ Advanced analytical and problem-solving skills.

+ Deep understanding of process and cleaning validations, commercialization strategies, and execution.

+ Ability to integrate multiple technology disciplines to advance programs.

+ Effective prioritization and multitasking capabilities.

+ Collaborative mindset with cross-functional teams.

Additional Information:

+ **Position Location:** US: Lebanon IN (LP1 site)

+ **Travel Percentage (%):** 5-30%

+ **Shift Information:** 8-hour shift, 5 days a week. Occasional night and weekend work may be required.

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

$129,000 - $209,000

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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