Associate Director – QC – IAPI Analytical Sciences

Eli Lilly and Company; Indianapolis (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical benefits

Pension

Job summary

Lilly in Indianapolis is seeking a talented QC Analytical Sciences leader to drive analytical capabilities, method development, and transfers while mentoring the Indianapolis API QC team.

You will partner with TS/MS and PAT, oversee stewardship of the analytical control strategy from late-stage development to commercialization, and ensure regulatory readiness, cost effectiveness, and continuous improvement of laboratory systems.

Qualifications

• 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.
• Authorized to work in the United States on a full-time basis. Lilly will not sponsor work authorization or visas for this role.

Responsibilities

• Lead the Indianapolis API QC Analytical Sciences team and develop technical capabilities for analytical stewardship, chromatography, Mass Spectroscopy, and PAT.
• Provide leadership and oversight for method development and transfers.
• Drive improvement of the analytical control strategy and modernization of laboratory equipment and processes.
• Identify and implement new technologies/methods that improve cost, compliance, or process control.
• Collaborate with site operations and TS/MS to develop innovative analytical solutions for process efficiency and product quality.
• Support regulatory inspections and ensure inspection readiness.

Education

Bachelor’s degree in a science field related to the laboratory

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• 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.
• 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

• Bachelor’s degree in a science field related to the laboratory (e.g., chemistry, microbiology or biology)

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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).

• 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.