Principal/Sr. Principal Bioprocess Scientist

5 months ago

Lebanon, United States Lilly Full time

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:

Parenteral drug product – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and execution of compliant manufacturing of gene therapy drug product. The scope of the role will initially focus on Drug Product filling & packaging and visual inspection operations, from facility startup through support of validation processes and commercial manufacturing.

Key Objectives/Deliverables

Provide technical support for all start-up TS/MS activities of parenteral drug product (e.g., filling & packaging, tech transfer, process validation, media & buffer recipe, formulation) Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps. 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. Participate in development and implementation of process improvements. Work within cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability Apply manufacturing process knowledge and data analysis skills to support the management of daily manufacturing operations Serve as technical interface external to the Lebanon site. Provide inspection support, as needed. Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Basic Requirements:

BS or MS in Engineering, Biochemical Engineering, Biochemistry or related quantitative field, and 3 years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, Engineering, or Quality Assurance. Must have experience with parenteral drug product manufacturing.

Additional Preferences:

In depth knowledge of gene therapy drug product manufacturing Experience using solution filling equipment and/or isolator technology Experience with serialization and packaging Experience with AAV drug product formulation, media and buffer preparation 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.

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