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 supports the execution of the portfolio of early phase development assets within PR&D, SMDD, and BRD.

Responsibilities

• 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.
• Capture and manage deviations and complaints.
• 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 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.

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.

Skills

• 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.

Benefits

• 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.

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Additional Information

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 $65,250 - $169,400.

In addition, Lilly offers a comprehensive benefit program to eligible employees, 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).