Lab Compliance Operations Jobs in Indiana (NOW HIRING)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
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.
About the Lilly Medicine Foundry:
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.
Organizational Overview:
Lilly is currently constructing an advanced research facility for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly's largest investment in a clinical trial 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.
We are seeking a Process Engineer to support the pilot plant facility in Lebanon, with a focus on small molecule Kilo Lab and High Potency Lab operations. This position involves solving technical challenges with kilo-scale reactor and scale-up equipment design, developing and sustaining process knowledge for both standard and high-potency (HPAPI) chemistries, optimizing processes across synthesis, crystallization, distillation, and isolation unit operations, and managing equipment capabilities and containment strategies for the Kilo Lab and High Potency Lab suites.
Responsibilities
The Process Engineer provides technical assessment and support for production operations in the areas of developing and sustaining process knowledge, process and equipment support, process optimization, equipment capability and asset management, and engineering business systems. This role is to serve as a process engineer supporting drug substance active pharmaceutical ingredient (API) manufacturing within the Kilo Lab and High Potency Lab.

• Evaluate scale-up feasibility and rig fit for new chemistries by analyzing technical data packages and running kinetic, mass-transfer, and heat-transfer modeling and experiments to ensure clean transfer from gram- to kilogram-scale reactors.

• Design, test and install new equipment to meet the evolving portfolio and reaction needs.

• Design, operate, and troubleshoot kilo-scale reactor systems - glass-lined and Hastelloy reactors, agitated filter-dryers - partnering with Kilo Lab and High Potency Lab chemists and shaping plant design for piping, mixing, heat transfer, and automation.

• Engineer containment and safe-handling strategies for HPAPI operations, spanning isolator and glove-box systems, occupational exposure banding (OEB), and dry-end solids processing.

• Optimize crystallization, distillation, extraction, and isolation unit operations, resolving polymorphism and particle-size challenges while closing mass balances and tracking impurity fate and purge across multi-step syntheses.

• Safeguard quality, safety, and cGMP compliance across equipment and procedures, and author or review technical reports, regulatory submissions, and lab notebooks to a high standard.

• Drive cross-functional execution by conducting impact and risk assessments, coordinating with HSE, QA, Tech Services, Development, Operations, Automation, and Manufacturing, and developing project plans and timetables with a proactive quality mindset.

• Develop or review plans and timetables for project work.

Basic Requirements:

• BS or MS in chemical engineering or related discipline and a minimum of 1-4 years of experience with a pharmaceutical, biotech, or CMO environment supporting the process engineering of drug substance active pharmaceutical ingredient (API) manufacturing or development.
• 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:

• Deep technical interest and understanding in the field of process development and chemical engineering

• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability

• Experience with any of the following software packages: DeltaV, Dynochem, Aspen, and/or electronic lab notebooks

• Experience with kilo-scale equipment (e.g., glass-lined/Hastelloy reactors, agitated filter-dryers) and understanding of scale-up factors including kinetics, mass transfer, and heat transfer

• Familiarity with high-potency API (HPAPI) handling, containment equipment (isolators, glove boxes), and occupational exposure banding (OEB) practices

• Working knowledge of key organic chemistry unit operations (crystallization, distillation, extraction) and analytical techniques (HPLC/UPLC, MS, NMR, GC, KF, DSC, XRD) Experience supporting small molecule process chemistry scale-up from gram to kilogram scale in a cGMP environment

• Working knowledge of bioconjugate unit operations including single use, TFF and chromatography.

• Strong analytical and problem-solving skills

• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.

• Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals

• Understanding of process control systems

• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented

• Guidance/mentoring of others through processes

• Flexibility to meet business needs

Other Information:

• Initial location at Parkwood West, Indianapolis.

• Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.

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 (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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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.
#WeAreLilly