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Associate Director

3 months ago

Durham, North Carolina, United States Eli Lilly and Company 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.

Overview:

Quality Control Associate Director (QC AD) is responsible for leading the QC organization for the Microbiological Labs and the Environmental/Utilities Monitoring team at the Lilly Research Triangle Park (RTP) site. The QC AD provides laboratory leadership and has responsibility for lab operations delivery, staffing and development, training/procedures and method delivery as the lab starts up in phased conjunction with production. Additionally, the QC AD will continue to help build a strong quality culture and lead the QC team for oversight and support of the ongoing operation as well as site inspection readiness and execution.


Responsibilities:

Demonstrated technical competency (method understanding) and leadership in a QC microbiology lab (e.g., sterility, bioburden, particulates, preservative effectiveness, microbial identification) Demonstrated technical competency (method understanding) and leadership in Environmental Monitoring of both traditional aseptic environments and isolators (e.g., viable monitoring – active and passive, non-viable monitoring, personnel monitoring). Understanding of Annex I requirements. Climet and MODA experience is extremely beneficial. Demonstrated technical competency (method understanding) and leadership in Utility Monitoring (e.g., Process Air, Water for Injection, Clean Steam). Experience with microbiology method transfer and compendial method verification. Experience with microbiology equipment commissioning and qualification. Experience with microbiology laboratory start-up operations. Demonstrated project management skills. Demonstrated administrative leadership of a diverse team including performance management and personnel development. Ability to utilize team through active engagement and delegation to achieve results through others and deliver according to plan. Ability to manage a complex change agenda in a fast-paced environment. Ability to manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates. Ability to demonstrate flexibility with quick response as priorities change or issues arise. Active communication on project status. Partner with QC Associate Director for Chemistry and Device Lab to set cohesive QC organization and operation. Partner with production and design operation to ensure 24/7 support for required testing and monitoring against production schedule Review and approve technical and GMP documents such as protocols, deviations, changes, summary reports, etc Ensure all aspects of safety are incorporated into the lab and maintain a safe work environment, including supporting all HSE Corporate and Site Goals. Establish connections with the Global Quality Lab Network and actively working with the network to support global initiatives. Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation. Define, lead and/or support inspection readiness activities for lab operations and interact with Regulatory agencies during inspections
Basic Requirements: Bachelor of Science in Microbiology/Biology or related science 7+ years GMP lab experience including use of aseptic technique, testing and method transfer Previous leadership experience including leading or working effectively with a cross functional group.
Additional Skills/Preferences: Deep understanding of compliance requirements and regulatory expectations Excellent written and oral communication skills Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems. Strong technical aptitude and ability to train and mentor others Project management experience Demonstrated problem-solving and decision making capability Demonstrated technical writing skills Proven cross-functional leadership
Additional Information: Ability to work 8 hour days – Monday through Friday Ability to work overtime and off shift as required to support a 24/7 manufacturing facility The position is onsite for the Lilly Research Triangle Park campus and allows for the ability to periodically work remotely (up to 4 days per month) based on the project phase, site and operational activities. Position may require periodic business travel (10%) to establish specific QC knowledge and establish global contacts. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly