Associate Director – QC – IAPI Analytical Sciences

Eli Lilly and Company • Indianapolis, IN

21h • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in a science field related to the laboratory (e.g., chemistry, microbiology or biology)
• 5 years of relevant experience in a cGMP lab.
• 2+ years supervisory experience
• Demonstrated strong data analysis and documentation skills.
• Demonstrated attention to detail, critical decision making, and problem-solving skills.
• Demonstrated strong oral and written communication and interpersonal interaction skills.
• Knowledge of cGMPs and quality systems.

Nice To Haves

• Experience in method development and validation
• Experience with a broad range of analytical techniques
• Knowledge of ICH guidelines applicable to analytical sciences
• Strong statistical skills
• BS/BA in Chemistry or science-related field, or comparable experience.

Responsibilities

• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees