Principal/Sr. Principal Bioprocess Scientist (Upstream) - Advanced Therapies Manufacturing

---

Job description

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.

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 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 at Lilly. It 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:

Upstream 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 and drug product 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. Understand the process control strategy for AAV and gene therapy products
• Provide technical support for all start-up TS/MS activities (e.g., tech transfer, process validation, process stewardship and improvement)
• Understand the scientific principles required for manufacturing AAV drug substances and products, including cell culture, bioreactor operation, vector production and aseptic processes
• 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 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 in a positive fashion 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 by actively participating in safety-related activities

Basic Requirements:

• BS in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or Engineering/Science related field
• 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering

Additional Preferences:

• In depth knowledge of gene therapy drug product manufacturing
• Experience with AAV vector purification
• Experience with cell line platforms for AAV cGMP manufacturing
• 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 that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems
• Demonstrated successful membership/leadership of cross-functional teams

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

<!– job description page –>