Sr. Advisor​/Director​/Sr. Director, TSMS- Advanced Therapies

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

** Introduction:*
* _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 expanding its portfolio of advanced therapy medicines, spanning viral vector (AAV and lentiviral) and non-viral delivery (lipid nanoparticle and mRNA) platforms. These are among the most technically demanding modalities in our network, combining rapidly evolving science with a fast-moving regulatory landscape, and are manufactured across both internal Lilly sites and external manufacturing partners._

*
* Job Title:

** Senior Advisor / Director / Senior Director - Technical Services/Manufacturing Science, Advanced Therapies

** Organization Overview*
* The TS/MS organization provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of Lilly's manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine. Within TS/MS, the central commercialization team provides global technical stewardship for products from early development through launch and across the commercial lifecycle, working across internal manufacturing sites and external partners.

** Responsibilities:*
* The successful candidate will serve as the technical lead and global technical owner for assigned advanced therapy drug substance programs, leading the technical strategy from early development through commercial launch and lifecycle management. This is an individual contributor and technical leadership role supporting a growing portfolio of multiple advanced therapy modalities. The role focuses on drug substance, spanning both drug substance and drug product for lipid nanoparticle products where the two are closely coupled.

Key responsibilities of the role include:

+ Partnering with development organizations, define and own the product control strategy, support establishment of specifications, monitor process capability, and set the technical improvement agenda for assigned products

+ Represent technical services on cross functional product and governance teams, providing technical positions on manufacturing readiness, process validation and ongoing product performance

+ Provide technical oversight of external contract manufacturing partners, including technology transfer, process comparability assessments, technical content for quality and technical agreements, and on-site support during manufacturing campaigns

+ Author and review CMC sections of regulatory submissions, manage responses to health authority questions, and support post-approval changes; apply global regulatory expectations and relevant ICH guidance for viral vector and nucleic acid products

+ Provide technical leadership on viral vector manufacturing challenges including transfection and producer cell line performance, downstream purification, and full/empty capsid separation

+ Provide technical leadership on lipid nanoparticle and mRNA manufacturing challenges including encapsulation efficiency, lipid analytics, and in vitro transcription performance

+ Partner with analytical development on potency, infectivity and subvisible particulate characterization strategy, and address cryogenic handling and cold chain integrity requirements for frozen products

+ Lead complex…