Principal Scientist QA

Early Phase Quality Assurance

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.

Early Phase Quality Assurance is accountable for GMP Quality dedicated to the PR&D Early Phase Team. This position is responsible for providing day to day Quality oversight of the Early Phase Teams and external partners in support of executing the portfolio of both early phase development assets within PR&D, SMDD and BRD.

Key Objectives/Deliverables:

• Support delivery of early phase Pre-Commercialization Information and Materials within the Early Phase portfolio (typically through Phase II); ensuring quality expectations/requirements are consistently met.
• Ensure appropriate execution of Early Phase Quality System to sustain compliance with regulatory requirements and good manufacturing practices
• Review and approve manufacturing documentation
• Disposition API, in-process materials, dosage forms and finished drug product to be used in Clinical Trials including management and review of GMP documentation, analytical results and regulatory commitments.
• Coordinate deviation and complaint investigations, as needed
• Review and approve deviations, change documents, and specifications for Early Phase materials
• Provide QA input to CM&C Development Plans as part of Early Phase deliverables.
• Ensure contract manufacturers and packagers, testing laboratories, vendors, and suppliers are qualified to assure compliance and integrity of the supply chain and oversee partner activities in a manner that optimizes compliance as well as efficiency.
• Collaborate with internal business and quality partners (SMDD,  &D, PD, ELECTS) to ensure appropriate Lilly oversight of Early Phase activities at external partners
• Provide on-site support at partners for manufacturing, packaging and labeling activities of investigational medicinal products, and materials used to produce IMPs as necessary.
• Identify opportunities for, and participate in, continuous improvement
• Ensure inspection readiness through site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems and provide support for internal and regulatory site inspections

Minimum Requirements:

• Minimum 5 years professional experience.
• Demonstrated relevant experience in global clinical trial cGMP regulations
• Breadth of technical and quality knowledge including at least 2 of the following: API, drug product manufacturing, clinical trial packaging, analytical laboratories & ADC.
• Previous experience in Large Molecule manufacturing and Antibody Drug Conjugation
• Ability to interpret/apply phase-appropriate GMP standards
• Proficiency with applicable computer systems.
• Demonstrated strong oral and written communication skills.
• Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.
• Demonstrated attention to detail.
• Experience in Data Handling and Data Integrity events/assessments.
• Change Management experience
• Deviation Management and Investigations

Additional Preferences:

• Proven ability to work independently or as part of a team to resolve an issue.
• Previous experience in QA, QC, Operations, TS/MS, Engineering, or Regulatory is desirable.
• Knowledge of PR&D Quality Systems and/or CT Operations is preferred
• Experience in cGMP Auditing

Education Requirements:

• Bachelor's degree in Science-related field or Engineering, or equivalent years of experience.

Other Information:

Travel US and OUS (including India and China) is required (10-20%) for collaboration partner oversight, training, conferences, etc.

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