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 to help build a state-of-the-art facility and Technical System from the ground up, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

POSITION DESCRIPTION:

Technical Lead – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical leadership and oversight to clinical and commercialization activities of gene therapy product at the Lebanon Advanced Therapies (LP2) site. The scope of the role includes all clinical trial and commercialization gene therapy products such as technology transfer, validation, drug substances and products production, inspection, submission and filing.
The TS/MS Technical Lead can be involved with clinical trials and supports all commercialization activities up to submission and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and LP2 commercialization procedures.
The TS/MS Technical Lead works with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process.

BASIC REQUIREMENTS:

• BS/MS in Biotechnology, Biochemistry or related quantitative field
• A minimum of 3 years of experience in pharma/biotech manufacturing industry
• Experience with new product submission and filing

Please refer the Job description for details