Senior Principal Associate, Small Molecule Process ...

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. Weu2019re looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Small Molecule facility will be responsible for the manufacture of drug substance (DS) produced via organic synthesis, which includes traditional small molecule medicines at multiple scales as well as high potency antibody drug conjugates. As the Foundry is currently in design and construction (startup phase anticipated completion in 2027), the initial position will be fluid and dynamic as we endeavor to support the delivery of the Foundry, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing facility. Once Small Molecule start up activities are completed, the Small Molecule Process Quality function will provide on-site quality oversight of GMP operations. Responsibilities u00b7 Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team. u00b7 Support cross-functional teams, facilitate decision making and drive progress. u00b7 Support the execution of the site operational readiness plan including development of early phase quality processes and operational procedures and controls. u00b7 Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams. u00b7 Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities. u00b7 Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc. u00b7 Work cross-functionally with the plant teams to develop processes, provide operational support, and issue management. u00b7 Assist with inspection readiness activities. u00b7 Facilitate decision making within the team under tight deadlines. u00b7 Effectively communicate with internal and external stakeholders. u00b7 Participate in global communities of practice and committees, as appropriate, to establish and maintain a network for benchmarking and share learning. u00b7 Identify and lead process improvement projects impacting multiple business areas. Basic Requirements: u00b7 BA/BS degree in Engineering, Science, or related field with a minimum of 5 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated in-dustry. u00b7 Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems. u00b7 Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Preferences: u00b7 Experience in API manufacturing of synthetic small molecules and/or high potent antibody drug conjugates (ADC). u00b7 Experience with applicable equipment cleaning requirements. u00b7 Relevant industry experience in high paced working environment. u00b7 Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration. u00b7 Demonstrated strong oral and written communication skills. u00b7 Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills. u00b7 Flexibility to adjust quickly and effectively to frequent changes and altered priorities. u00b7 Ability to input and influence decision making for complex technical issues. u00b7 Ability to establish key relationships and influence peers and business partners. u00b7 Ability to identify and prioritize issues and develop & implement solutions. u00b7 High learning agility and ability to deal with ambiguity, uncertainty. u00b7 Demonstrated attention to detail. Other Information: u00b7 Position Location: US: Lebanon IN Lilly Medicine Foundry Operations; initial location in Indianapolis, IN during startup phase u00b7 Travel Percentage: 5% - 15% u00b7 May be required to provide on-call support outside of normal working hours including nights, weekends, and holidays. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly 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), Womenu2019s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidateu2019s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 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 Lillyu2019s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Created: 2026-02-05