Bioprocess Scientist - Advanced Therapies Manufacturing – LNP-mRNA

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 implementing new technologies and process improvements in the manufacturing environment. Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy at Lebanon, Indiana. The successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

Responsibilities

Provide technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture; Build deep technical expertise in the area of responsibility; Provide technical support for start-up TS/MS activities (NPI, tech transfer, process validation, process stewardship and improvement); Own and technically steward bioprocess, including Root Cause Analysis for deviations and Impact Assessments for changes; Work in cross-functional teams to bring technical expertise to operations; Assess whether the process is in control and capable; Identify process improvements and participate in Lean manufacturing initiatives; Prepare, review, approve and support technical documents (change controls, regulatory submissions, deviation investigations, validation protocols, summary reports, processing records, process descriptions, annual reports); Support or lead TS/MS technical projects; Develop, monitor and react to statistically based metrics in real time; Serve as technical interface external to the Lebanon site; Provide audit support; Ensure a safe working environment and improve safety culture

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.); Must be authorized to work in the United States on a full-time basis (Lilly will not provide sponsorship or visas for this role)

Nice to have

In-depth knowledge of the science behind the molecule and processes on mRNA/LNP drug substance manufacturing; Understanding of 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

Benefits

Company bonus (depending on company and individual performance); Company-sponsored 401(k); Pension; Vacation benefits; Medical, dental, vision and prescription drug benefits; Flexible benefits (healthcare and/or dependent day care flexible spending accounts); Life insurance and death benefits; Time off and leave of absence benefits; Well-being benefits (employee assistance program, fitness benefits, employee clubs and activities)