Senior/Principal Scientist - Quality Control Project Manager

Role Summary

The Senior/Principal Scientist - Quality Control Project Manager provides planning, coordination, and technical leadership for quality control testing of products managed by the Lilly Lebanon Advanced Therapies Manufacturing (LP2) team. The role serves as a liaison between internal teams, contract manufacturers, and external partners to ensure testing and control of products meet predefined standards. Responsibilities include overseeing transfer of analytical methods, data interpretation, project management, and supporting inspection readiness and continuous improvement. Based in Lebanon, IN with up to 20% travel.

Responsibilities

• Serve as a liaison between contract manufacturers and Lilly to coordinate, review, and interpret quality control product testing data and act as the initial point of contact for quality control-related issues.
• Provide analytical support, project leadership, and/or technical direction for testing performed internally to LP2 or by third-party contract partners.
• Oversee and participate in the transfer of analytical methods, including setting strategic direction, authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations.
• Identify appropriate subject matter experts to lead or perform in-depth investigations into out-of-spec results and aberrant data.
• Track project progress and performance, maintaining transparent project documentation (timelines, budgets, status) accessible to all team members and partners.
• Define project scope, objectives, and deliverables; develop detailed project plans with timelines, milestones, and resource allocation; ensure alignment with organizational goals.
• Provide technical oversight for Periodic Management Reviews; lead resolution of technical issues related to control strategy and manufacturing.
• Foster a strong quality culture through open communication, teamwork, and employee participation in the work group.
• Interact effectively with business partners and auditors to communicate and resolve issues and understand each other‚Äôs requirements.
• Network with internal and external Lilly groups to share best practices, participate in technical planning, and ensure customer needs are met.
• Help define and execute inspection readiness activities for manufactured products.
• Maintain excellent communication to manage internal and external relationships, conduct effective investigations, and disseminate actionable outputs.
• Build and maintain relationships with development partners and central technical organizations.

Qualifications

• Required: Bachelor‚Äôs (4-year) degree in a science field related to chemistry, microbiology, or biology.
• Required: 4+ years of demonstrated relevant experience in a GMP manufacturing environment.
• Preferred: Demonstrated proficiency in project management, data management practices, and ability to coordinate complex projects.
• Preferred: Ability to manage and prioritize competing priorities and to communicate verbally and in writing to various audiences.
• Preferred: Strong oral and written communication skills demonstrated through documentation and presentation.
• Preferred: Proficiency in delivering complex tasks and cross-functional work.
• Preferred: Experience with large molecule and/or viral vector testing techniques.
• Preferred: Root Cause Analysis training and proficiency.
• Preferred: Strong interpersonal skills and focus on continuous improvement; deep understanding of compliance requirements and regulatory expectations.

Education

• Bachelors (4-year) degree in a science field related to chemistry, microbiology, or biology.

Additional Requirements

• May require up to 20% travel, including overseas, requiring a passport.
• Role is located in Lebanon, IN and requires on-site attendance within policy when not traveling for work-related responsibilities.