Bioprocess Scientist - Advanced Therapies Manufacturing – LNP-mRNA

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.

Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products  will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.

This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Position

Description:

Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture. The successful candidate will be required to build deep technical expertise in their area of responsibility (including in-depth knowledge of the science behind the molecule and the process), have strong working skills on the manufacturing equipment set and control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities.

They may also work to ensure that the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring and may play a role in by implementing new technologies and process improvements in the manufacturing environment.

Key Objectives/Deliverables

Have an in-depth knowledge of the science behind the molecule and the processes, specifically LNP-mRNA molecules.

Understand the process control strategy for gene therapy products.

Provide technical support for all start-up TS/MS activities (e.g., NPI, tech transfer, process validation, process stewardship and improvement).

Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes

Work as part of cross-functional teams, and establish partnerships with applicable functions, operations, and development to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team.

Be able to assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation.

Identify process improvements and participate in implementation of Lean manufacturing initiatives.

Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process…