QC Associate Director

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 staffMaintain a safe work environmentEnsure GMP complianceEnsure 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 objectivesInteract with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency auditsEnsure adequate oversight and technical excellence for investigations and complaintsCollaborate 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 portfolioProvide oversight for technical projects to improve process control, capacity, yield, and qualityEnsure adequate technical representation and engagement within the site and network governance meetings to influence technical agendasNetwork globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sitesEngage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercializationMinimum Qualifications:Bachelor’s Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field5+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environmentExtensive knowledge of a variety of chromatographic methods (e.g., LC, GC) and related analytical techniques (e.g., MS, spectroscopy, etc.)Additional Preferences:Ability to influence and lead diverse groupsExperience with complex regulatory, business, or technical issues for pharmaceutical manufacturingStrong analytical and quantitative problem-solving skillsExperience with Empower softwareExperience with LIMS implementation and use within a manufacturing environmentExperience with statistical analysis of dataTechnical leadership, administrative and organizational skillsProficiency in delivering highly complex tasks and/or tasks that are highly cross-functionalDemonstrated Project Management skills and ability to coordinate complex projectsAbility to communicate and influence effectively across functional groups and stakeholdersStrategic thinking and ability to balance short term needs with long term business evolutionAbility to build relationships with internal and external customers and partnersEnthusiasm for changes, team spirit and flexibilityDemonstrated ability to learn & apply technical/scientific knowledgeAdditional Information:Minimal travel ( Some off-shift work (nights/weekends) may be required to support 24/7 operationsLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLillyAbout Us

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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