Principal Scientist QA
Eli Lilly and Company
August 24, 2026
On-site
Indianapolis, IN
Operations
Position Brand Description
Early Phase Quality Assurance (GMP Quality) accountable for the PR&D Early Phase Team, providing day-to-day Quality oversight of Early Phase Teams and external partners to execute the early phase development portfolio.
Key Objectives/Deliverables
- Support delivery of early phase pre-commercialization information/materials (typically through Phase II), ensuring quality expectations are met.
- Execute Early Phase Quality System to sustain compliance with regulatory requirements and GMP.
- Review and approve manufacturing documentation.
- Disposition API, in-process materials, dosage forms, and finished drug product for Clinical Trials (including review of GMP documentation, analytical results, and regulatory commitments).
- Coordinate deviation and complaint investigations; review/approve deviations, change documents, and specifications.
- Provide QA input to CM&C Development Plans.
- Qualify contract manufacturers/packagers, testing labs, vendors, and suppliers; oversee partner activities to optimize compliance and efficiency.
- Collaborate with internal partners (SMDD, BR&D, PD, ELECTS) to ensure appropriate oversight of external Early Phase activities.
- Provide on-site support for manufacturing/packaging/labeling of investigational medicinal products (as needed).
- Participate in continuous improvement; ensure inspection readiness (self-assessments, GMP education, quality systems, support for internal/regulatory inspections).
Minimum Requirements
- 5+ years professional experience; global clinical trial cGMP experience.
- Breadth of technical/quality knowledge (at least 2): API, drug product manufacturing, clinical trial packaging, analytical labs, ADC.
- Large Molecule manufacturing and Antibody Drug Conjugation experience.
- Interpret/apply phase-appropriate GMP; proficiency with applicable computer systems.
- Strong communication; critical thinking/problem-solving (root cause analysis); attention to detail.
- Data handling/integrity experience; change management; deviation management/investigations.
Additional Preferences
- Independent/team issue resolution; prior QA/QC/Operations/TS/MS/Engineering/Regulatory experience.
- PR&D Quality Systems and/or CT Operations knowledge; cGMP auditing experience.
Education
- Bachelor’s degree in a Science-related field or Engineering, or equivalent experience.
Other Information
- Travel US and OUS (including India and China) required (10–20%).
Compensation/Benefits
- Anticipated wage: $65,250–$169,400. Company bonus eligibility and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).
Application Instructions
- Internal candidates should apply through Lilly’s internal job posting system and meet the minimum qualifications; discuss with your supervisor prior to applying.
Early Phase Quality Assurance (GMP Quality) accountable for the PR&D Early Phase Team, providing day-to-day Quality oversight of Early Phase Teams and external partners to execute the early phase development portfolio.
Key Objectives/Deliverables
- Support delivery of early phase pre-commercialization information/materials (typically through Phase II), ensuring quality expectations are met.
- Execute Early Phase Quality System to sustain compliance with regulatory requirements and GMP.
- Review and approve manufacturing documentation.
- Disposition API, in-process materials, dosage forms, and finished drug product for Clinical Trials (including review of GMP documentation, analytical results, and regulatory commitments).
- Coordinate deviation and complaint investigations; review/approve deviations, change documents, and specifications.
- Provide QA input to CM&C Development Plans.
- Qualify contract manufacturers/packagers, testing labs, vendors, and suppliers; oversee partner activities to optimize compliance and efficiency.
- Collaborate with internal partners (SMDD, BR&D, PD, ELECTS) to ensure appropriate oversight of external Early Phase activities.
- Provide on-site support for manufacturing/packaging/labeling of investigational medicinal products (as needed).
- Participate in continuous improvement; ensure inspection readiness (self-assessments, GMP education, quality systems, support for internal/regulatory inspections).
Minimum Requirements
- 5+ years professional experience; global clinical trial cGMP experience.
- Breadth of technical/quality knowledge (at least 2): API, drug product manufacturing, clinical trial packaging, analytical labs, ADC.
- Large Molecule manufacturing and Antibody Drug Conjugation experience.
- Interpret/apply phase-appropriate GMP; proficiency with applicable computer systems.
- Strong communication; critical thinking/problem-solving (root cause analysis); attention to detail.
- Data handling/integrity experience; change management; deviation management/investigations.
Additional Preferences
- Independent/team issue resolution; prior QA/QC/Operations/TS/MS/Engineering/Regulatory experience.
- PR&D Quality Systems and/or CT Operations knowledge; cGMP auditing experience.
Education
- Bachelor’s degree in a Science-related field or Engineering, or equivalent experience.
Other Information
- Travel US and OUS (including India and China) required (10–20%).
Compensation/Benefits
- Anticipated wage: $65,250–$169,400. Company bonus eligibility and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).
Application Instructions
- Internal candidates should apply through Lilly’s internal job posting system and meet the minimum qualifications; discuss with your supervisor prior to applying.