Principal Scientist QA

About the Role

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 the 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, BR&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.

Requirements

• Minimum 5 years of 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, and 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.

Preferred Qualifications

• 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

Bachelor’s degree in a 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.

Pay

The anticipated wage for this position is $65,250 - $169,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Comprehensive benefit program including 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits.