Associate Director - TSMS; Molecule

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
40,000 employeesaround 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’relooking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced manufacturing facility for production of API moleculeslocatedin Houston, TX.This facility is intended to provide APIs for current and future products, including new modalities.

This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, thefacilityand the culture to enable a successful startup into GMP manufacturing operations.

The TS/MS Associate Directoris responsibleforleading/mentoring a technical staff and understandingchemical synthesis processing as it relates to cGMP API commercial manufacturing.

This role is responsible to manageroutine production support activities while balancing implementation of technical projects and process optimizations, providing guidance on time management and priorities for direct reports.

Key position responsibilities aresupporting technical transfer of new processes to site,developing and executing the process and process-related validation plans,establishingcontrol and capability of the process, and maintaining GMP compliance in all associated documents and activities. The position requires knowledge ofcGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.

This position will interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments to influence and implement the technical agenda within a multi-discipline technical environment.

Interaction mayberequiredwith other Lilly site/contract producers of Lilly products.

• Responsible formaintaininga safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Hire, manage and grow a team of scientists tasked withsupportoftechnology transfer, process validation,manufacturing operations,and continuous improvement. Accountable for the performance and results of the TSMSproduction support function.
• Hiring, performance management,and development of staff
• Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business planobjectivesand GMP Quality Plan objectives
• Ensure adequate oversight and technical excellence for investigations and complaints.
• Technical review and approval for site quality documents, plans, regulatory submissions, validation-related documents, and studies.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
• Define strategic direction and provide oversight forsettingthe technical agenda to improve process capability, process control, yield, and/or productivity for all products within the site portfolio.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

• Bachelors or Masters in Chemistry,…