Associate Director QC IAPI Analytical Sciences

Quality Control (QC) Associate Director (AD) Analytical Sciences

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.

The Indianapolis API site has a long legacy of operating with technical excellence while producing lifesaving medicines for many decades. We are currently executing a complex modernization and transformation effort across the site that includes a strong analytical agenda. We are seeking a talented individual that can provide technical leadership and mentoring to drive analytical initiatives and improvements.

The Quality Control (QC) Associate Director (AD) Analytical Sciences is responsible for leading the Indianapolis API QC Analytical Sciences team by establishing key capabilities needed to support site operations, QC, and commercialization work within IAPI. The Analytical Sciences team provides stewardship of the analytical control strategy. The position also influences the analytical control strategy from late stage development to commercialization. This role requires cross-functional collaboration with TS / MS and PAT to support site and network initiatives.

Key Objectives / Deliverables :

• Uphold company values of Integrity, Excellence, and Respect for People.
• Ensure employees maintain required training and adhere to company policies and guidelines.
• Recruit and manage team members' performance.
• Develop and execute a comprehensive technical capability strategy to ensure site competencies in fields including but not limited to analytical stewardship, chromatography, Mass Spectroscopy, and Process Analytical Technology.
• Provide leadership and oversight for method development and transfers.
• Drive improvement of the analytical control strategy, continuous optimization of methods leveraged in the laboratory, and continued modernization of equipment and processes used within the laboratory.
• Identify and support the implementation of new technologies / methods that offer significant advantages in cost reduction, compliance improvement or process control.
• Prioritize analytical initiatives based on business impact and risk analysis.
• Provide resources and oversight to ensure the analytical control strategy from raw materials through drug substance is technically sound, cost effective, compliant and sustainable for specific molecules.
• Provide resources and oversight for the troubleshooting and investigation of major analytical issues.
• Collaborate with site operations and TS / MS to develop innovative analytical solutions that drive process efficiency and product quality.
• Support global Analytical Quality Control Organization initiatives as applicable.
• Review and / or approve documents as required.
• Support regulatory inspections and ensure inspection readiness.
• Develop and implement technical coaching and mentoring strategy.

Basic Requirements :

Additional Preferences :

Education Requirements :

Other Information :

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Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.