At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world.
Mission Statement
We are a global healthcare leader based in Indianapolis. Our employees 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.
Key Responsibilities
The Associate Director – Technical Services/Manufacturing Science (TSMS) API External Manufacturing role is responsible for overseeing the activities of TSMS personnel supporting externally manufactured Small Molecules.
* Balancing coaching a technical staff, prioritization and staffing for routine production support activities
* Implementation of technical projects, technical transfers, commercialization and process optimization
This position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards for validation.
Required Skills and Qualifications
This role requires working cross-functionally within the site, network, commercialization teams, and multiple global suppliers to deliver on technical objectives, specific product business plan, and quality objectives.
* Technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
* Performance management and development of technical staff
This role will interact with suppliers, regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
About Us
Eli Lilly and Company is dedicated to ensuring equal opportunities for individuals with disabilities when vying for positions.