Eli Lilly and Company
Sr. Director – Analytical Chemistry Quality Control Laboratory
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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.Lilly is currently expanding its global manufacturing footprint and is looking for experienced QC Chemistry Laboratory leaders to provide leadership for a team of experienced analytical scientists who oversee testing related to manufacturing operations in Indiana.The Sr. Director – QC Quality Control Chemistry Laboratory provides administrative leadership for the Analytical Chemistry Quality Control laboratories and ensures appropriate capabilities and business processes are developed and maintained in a manufacturing site. This position involves working cross-functionally within the site and across the network to develop the strategic functional capabilities needed to support the mission of the site. This role is responsible for the oversight and execution of chemical product testing, including tests for raw materials, in-process samples, semi-finished and finished products.Responsibilities:
Business Support
Maintain a safe work environment that complies with regulations, lead safety initiatives within the Quality Labs and across the site.Build a high-quality organization in support of Quality Laboratory Operations.Maintain GMP Compliance in all Laboratory Operations.Deliver the lab of the future vision for LP1 including integrated digital, paperless processes.Participate on the local area lead teams and Quality Lead Team.Work closely with Global Quality Laboratories and Global QC Operations to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems.Exhibit critical business decision-making bringing about successful results.Communicate to and strive for integration of support groups outside plant.Coordinate laboratory related business planning and budget management.Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met.Network with other sites regarding new systems development and standardization of processes.Compliance Oversight
Ensure CGMP quality and compliance deliverables are met across laboratories and a robust inspection readiness program is in place.Coordinate and manage all regulatory and internal inspections.Personnel Development
Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports.Ensure Human Resource Processes are established and maintained across the QCL organization.Recruit new talent and develop site capabilities to deliver a high functioning QCL organization.Ensure administrative and technical capability within the organization.Basic Requirements:
Bachelor’s degree in chemistry or related discipline.Minimum of 10 years supporting complex analytical testing (mass spec, bioassay, protein characterization).10 years leadership experience.Additional Skills/Preferences:
Knowledge of QC operations, new product introduction, and process development support.Expertise in CGMP quality and compliance requirements for analytical laboratories.Experience with regulatory submissions.Proficiency with computer systems including Microsoft Office products.Demonstrated technical writing ability.Demonstrated strong oral and written communication.Demonstrated interpersonal skills with the ability to lead leaders and influence cross-functionally and externally.Demonstrated ability to maintain a safe work environment.Additional Information:
Flex hours possible.Primary location is Indiana.Ability to travel (approximately 10%).Lilly 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance.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.
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Business Support
Maintain a safe work environment that complies with regulations, lead safety initiatives within the Quality Labs and across the site.Build a high-quality organization in support of Quality Laboratory Operations.Maintain GMP Compliance in all Laboratory Operations.Deliver the lab of the future vision for LP1 including integrated digital, paperless processes.Participate on the local area lead teams and Quality Lead Team.Work closely with Global Quality Laboratories and Global QC Operations to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems.Exhibit critical business decision-making bringing about successful results.Communicate to and strive for integration of support groups outside plant.Coordinate laboratory related business planning and budget management.Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met.Network with other sites regarding new systems development and standardization of processes.Compliance Oversight
Ensure CGMP quality and compliance deliverables are met across laboratories and a robust inspection readiness program is in place.Coordinate and manage all regulatory and internal inspections.Personnel Development
Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports.Ensure Human Resource Processes are established and maintained across the QCL organization.Recruit new talent and develop site capabilities to deliver a high functioning QCL organization.Ensure administrative and technical capability within the organization.Basic Requirements:
Bachelor’s degree in chemistry or related discipline.Minimum of 10 years supporting complex analytical testing (mass spec, bioassay, protein characterization).10 years leadership experience.Additional Skills/Preferences:
Knowledge of QC operations, new product introduction, and process development support.Expertise in CGMP quality and compliance requirements for analytical laboratories.Experience with regulatory submissions.Proficiency with computer systems including Microsoft Office products.Demonstrated technical writing ability.Demonstrated strong oral and written communication.Demonstrated interpersonal skills with the ability to lead leaders and influence cross-functionally and externally.Demonstrated ability to maintain a safe work environment.Additional Information:
Flex hours possible.Primary location is Indiana.Ability to travel (approximately 10%).Lilly 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance.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.
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