Bioprocess Scientist - Advanced Therapies Manufacturing – LNP-mRNA
Eli Lilly and Company
Summary
The 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 build deep technical expertise in their area of responsibility, have strong working skills on the manufacturing equipment set and control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities.
Job description
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
- 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 relevant technical documents such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents and annual reports
- Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity
- Implement process changes and improvements through the technical agenda
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
- Serve as technical interface external to the Lebanon site
- Provide audit support, as needed
- Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business plan and quality objectives
- Ensure a safe working environment through compliance with safety rules and improve safety culture
Basic Requirements
- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field
- 3+ years experience supporting cGMP manufacturing of LNP-mRNA molecules (specifically within Operations, TS/MS, Engineering, etc.)
- Qualified applicants must be authorized to work in the United States on a full-time basis
Additional Preferences
- In-depth knowledge of the science behind the molecule and the processes on mRNA/LNP drug substance manufacturing
- Understand the process control strategy for mRNA/LNP mediated gene therapy products
- Experience and understanding of technical challenges with mRNA as a therapeutic modality
- Experience with mRNA/LNP formulation
- Experience with QC assays in line with product CQAs including variability
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
- Strong oral and written communication skills
- Experience with data trending and analysis
- Ability to analyze complex data and solve problems
- Demonstrated successful membership/leadership of cross-functional teams
Requirements
- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field
- 3+ years experience supporting cGMP manufacturing of LNP-mRNA molecules
- Must be authorized to work in the United States on a full-time basis
- No visa sponsorship available
- In-depth knowledge of mRNA/LNP drug substance manufacturing
- Experience with mRNA/LNP formulation
- Experience with QC assays in line with product CQAs
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
- Strong oral and written communication skills
- Experience with data trending and analysis
- Ability to analyze complex data and solve problems
- Demonstrated leadership of cross-functional teams
Benefits
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.