QC Associate Director

1 day ago

Lebanon, United States Eli 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.
Organization Overview:
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Main Purpose and Objectives:
The Associate Director – Quality Control is part of the Lilly Lebanon API QC team for the Lilly Lebanon API site (LP1). The Assoc. Dir. – QC provides technical leadership and expertise in the development, performance, and maintenance of the Chromatography Lab throughout the start-up, implementation, and day-to-day operations of LP1.
The Assoc. Dir. – QC must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The Assoc. Dir. – QC will work cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
In the project delivery and start-up phase of the LP1 site (2025 to 2027), the Assoc. Dir. – QC will be flexible in supporting project delivery, building a new organization, developing and implementing the necessary systems and business processes required to support GMP operations, and building the site culture. This will require significant collaboration, creativity, and resilience as the site grows to a full-scale GMP manufacturing operation.
Key Responsibilities:
Provide technical leadership, performance management, training and development of staff
Maintain a safe work environment
Ensure GMP compliance
Ensure 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.
Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
Ensure adequate oversight and technical excellence for investigations and complaints
Collaborate with QC team to develop the strategy for the technical agenda to improve process control, yield, efficiency and productivity for all products within the site portfolio
Provide oversight for technical projects to improve process control, capacity, yield, and quality
Ensure adequate technical representation and engagement within the site and network governance meetings to influence technical agendas
Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
Engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization
Minimum Requirements:
Bachelor’s Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field
5+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment
Extensive knowledge of a variety of chromatographic methods (e.g., LC, GC) and related analytical techniques (e.g., MS, spectroscopy, etc.)

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