Process Systems Engineer

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.

Lilly's Product Research and Development (PRD) is involved in key activities for the development of active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products for biologics, small molecules, synthetic oligonucleotides, peptides, conjugates and other modalities. Our scientists develop key technical and business solutions across the portfolio using their deep technical expertise to speed up testing of the clinical hypothesis and overall drug development.

PRD tackles this diversity of responsibilities by recognizing that an even greater diversity of talents and cultures is necessary to deliver the next generation of life changing medicines to patients.

PRD is seeking outstanding process system engineering candidates to work within the Process Systems Engineering team. The position presents an opportunity to develop and apply computerized model-based solutions to accelerate the development of new medicines. It also presents the chance to work side by side with chemists, analytical chemists, formulation scientists, engineers and biologists to develop new technical solutions to accelerate our portfolio.

This position will be based in Indianapolis where research is conducted in a new, state of the art development facility. The ideal candidate must demonstrate a history of strong technical depth, scientific leadership, and a willingness to promote a collaborative, team-based approach to problem solving.

The responsibilities and opportunities for this role include:

* Apply process systems engineering fundamentals towards designing and optimizing pharmaceutical manufacturing processes including but not limited to solids operations, chemical reactions, separation processes, bioprocessing (upstream/downstream) using modeling, simulation and optimization tools in conjunction with data analysis.

* Design appropriate strategies to apply a variety of computational tools to support the development and scale-up of pharmaceutical manufacturing processes.

* Implement and execute the necessary data analysis, models and/or simulations to support to the design or scale-up of pharmaceutical manufacturing processes.

* Analyze and interpret data collected from laboratory experiments and/or from manufacturing (including parameter estimation).

* Actively participate in the design of process conditions for process understanding (experiments) or for material production in manufacturing (nominal conditions).

* Understand and utilize thermodynamics and material characterization techniques as an informing factor to model-based solutions.

* Develop user-friendly computational tools to be deployed across PRD to support the development of specific manufacturing platforms.

* Train the PRD general community in the use of platform computational tools.

* Serve as a member of integrated commercial teams responsible for the development and demonstration of new processes.

* Take leadership in the supervision of the compliance with regulations, guidelines, procedures, and practice governing drug research and development, including the departmental and corporate standard operating, good manufacturing practices, and safety procedures.

* Collaborate closely with multifunctional organizations such as Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions.

* Develop the external manufacturing network, oversee activities and install key capabilities within contract manufacturing organizations (CMOs).

* Engage in a highly collaborative work environment across and beyond PRD and Lilly, including external academic researchers and pre-competitive collaborations.

* Direct and mentor less experienced scientists and engineers to deliver the portfolio and innovation projects.

* Promote diverse thought and experience to deliver innovative solutions that address unmet technical needs.

* Publish and present original research externally, author internal technical documents and develop and document control strategies for new product registration applications (manufacturing process and development history portions).

Additional Skills and Preferences:

* Experience across multiple disciplines of process systems engineering (modeling, optimization, control, statistics, numerical methods, programming).

* Knowledge and experience building fundamental, empirical or hybrid models…