Principal Process Engineer - Purification, Lilly Medicine Foundry

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 experienced Process Engineers to support purification of biologics, peptides, oligonucleotides, and bioconjugates. This position involves solving technical challenges with equipment design, developing and sustaining process knowledge, optimizing processes, and managing equipment capabilities.

Responsibilities:

The Principal 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. In addition, the principal process engineer is expected to mentor newer engineers, drive cross-functional discussions, and proactively solve problems with a data-driven approach. This role is to serve as a process engineer supporting drug substance active pharmaceutical ingredient (API) manufacturing operations for oligonucleotide, peptide, and bioconjugate purification.

• Perform impact and risk assessments for the relevant equipment (chromatography skids/columns, TFF skids, etc.) and unit operations

• Drive progression of design, qualification supporting documentation, and delivery of purification equipment. This includes representing the process engineering team in Facility Acceptance Testing for assigned equipment.

• Perform equipment walkdowns throughout commissioning and qualification processes to proactively identify issues and provide paths forward to enable on time facility delivery.

• Participate in automation recipe and procedure discussions providing direction on how the equipment needs to be operated to deliver processes

• Mentor junior engineers and drive team technical projects

• Demonstrate a safety-first mindset and ensure that people and their environment are safe and that company policies concerning safety are followed.

• Ensure processing equipment remains compliant with internal Quality System requirements, applicable engineering standards, and cGMP requirements.

• Assess rig fit by receiving the technical data package for new processes and performing modeling, simulations and/or experimental work as required to ensure heat and mass transfer are acceptable when scaling to the plant

• Active engagement and communication with: HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing

• Author, review, or approve high-quality technical reports and regulatory submissions dealing with the work performed by the department. Ensure that records and technical notebooks are adequately maintained

• Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.

• Develop or review plans and timetables for project work.

Basic Requirements:

• BS or MS in chemical engineering or related discipline and a minimum of 5 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 Chemical Engineering

• Ability to work well in a team environment incorporating a variety of functional relationships, mentoring and providing feedback, and desire to be point of accountability for a variety of equipment

• Knowledge and experience with equipment and control strategies for the following unit operations: reverse phase chromatography, column packing, anion exchange chromatography, fractionation, solvent based processing, tangential flow filtration, annealing, distillation, lyophilization, and enzymatic ligation.

• Troubleshooting and root cause analysis in a GMP production environment

• Understanding of drug substance development lifecycle from Tox through commercialization

• Experience with any of the following software packages: DeltaV (preferred), Rockwell, OSI-PI, Dynochem, Aspen, and/or electronic lab notebooks

• 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 and principles

• 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 Lilly Technology Center, Indianapolis.

• Permanent location at the new Lilly Medicines 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.

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