Associate Director – QC – IAPI Analytical Sciences at Lilly

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

180400.0

Posted On

15 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Leadership, Mentoring, Analytical Initiatives, Analytical Control Strategy Stewardship, Method Development, Method Transfers, Chromatography, Mass Spectroscopy, Process Analytical Technology, Data Analysis, Documentation, Problem-Solving, cGMPs, Quality Systems, Method Validation, ICH Guidelines

Industry

Pharmaceutical Manufacturing

Description

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. Position Brand Description: 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: 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. Additional Preferences: 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 Education Requirements: BS/BA in Chemistry or science-related field, or comparable experience. Other Information: On-site presence required. 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. 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 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. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. 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, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Responsibilities

The Associate Director leads the Indianapolis API QC Analytical Sciences team, establishing capabilities to support site operations, QC, and commercialization work, while also influencing the analytical control strategy from late-stage development through commercialization. Key deliverables include developing a technical capability strategy, providing leadership for method development and transfers, and driving continuous optimization of laboratory methods and processes.