Bioprocess Scientist - Advanced Therapies Manufacturing – LNP-mRNA

Lilly • Lebanon, IN

4d • $67,500 - $173,800

About The Position

Lilly is building a technically advanced manufacturing facility in Lebanon, Indiana, for new modalities including gene therapy. This greenfield site will use next-generation manufacturing technologies and advanced data collection and analysis platforms. The successful candidate will help design, commission, and start up the facility for clinical and commercial supply, including helping establish its Quality System. The TS/MS team owns technology transfer, process validation, and process stewardship.

The Bioprocess Technical Services/Manufacturing Scientist provides technical support for the development, implementation, and transfer of compliant gene therapy drug-substance manufacturing processes for clinical and commercial production, with a focus on LNP-mRNA molecules. The role requires developing deep expertise in the science of the molecule and process, manufacturing equipment and control systems, and data-driven problem-solving. The scientist helps monitor and maintain processes in a controlled, capable, compliant, and validated state and may implement new technologies and process improvements.

Requirements

• Bachelor of Science degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related quantitative field.
• At least 3 years of experience supporting cGMP manufacturing of LNP-mRNA molecules, such as in Operations, TS/MS, or Engineering.
• Authorization to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

• In-depth knowledge of the science and processes involved in mRNA/LNP drug-substance manufacturing.
• Understanding of process control strategies for mRNA/LNP-mediated gene therapy products.
• Experience and understanding of technical challenges associated with mRNA as a therapeutic modality.
• Experience with mRNA/LNP formulation.
• Experience with QC assays aligned with product critical quality attributes, including variability.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.
• Strong oral and written communication skills, including the ability to communicate clearly and succinctly with all organizational levels.
• Experience with data trending and analysis.
• Ability to analyze complex data and solve problems.
• Demonstrated successful membership or leadership of cross-functional teams.

Responsibilities

• Develop in-depth knowledge of LNP-mRNA molecules, their underlying science, manufacturing processes, and process control strategy.
• Provide technical support for start-up TS/MS activities, including new product introduction, technology transfer, process validation, process stewardship, and process improvement.
• Own and technically steward bioprocesses; provide expertise for root cause analyses of deviations and impact assessments for changes.
• Work with cross-functional teams and partner functions, operations, and development to connect science and engineering with manufacturing-floor operations.
• Assess whether processes are in control, capable of meeting their purpose, and maintained in a validated state.
• Identify process improvements and participate in Lean manufacturing initiatives.
• Prepare, review, approve, and support technical documents such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents, and annual reports.
• Support or lead technical projects that enable start-up and improve process control, yield, product quality, or productivity; implement changes and improvements through the technical agenda.
• Develop and monitor statistically based metrics and respond appropriately to assess process variability and capability in real time.
• Serve as a technical interface external to the Lebanon site and provide audit support as needed.
• Work within or lead cross-functional teams to deliver TS/MS objectives, business plans, and quality objectives.
• Help ensure a safe working environment by following safety rules and participating in safety-related activities.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level