Principal Scientist QA

Eli Lilly and Company; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly seeks an experienced QA professional to provide day-to-day quality oversight of Early Phase teams and external partners, ensuring GMP compliance for pre-commercialization activities and clinical trial materials through Phase II.

The role requires reviewing manufacturing documentation, managing deviations and investigations, and coordinating with CMOs, labs, and suppliers to sustain regulatory readiness. Travel may be required.

Qualifications

• Minimum 5 years professional experience.
• Experience with global clinical trial cGMP regulations.
• Broad technical and quality knowledge across API, drug product manufacturing, clinical trial packaging, analytical labs & ADC.

Responsibilities

• Provide day-to-day QA oversight for Early Phase teams and external partners.
• Ensure GMP compliance and regulatory readiness for clinical materials through Phase II.
• Review/make decisions on manufacturing documentation, deviations, investigations and change controls.
• Coordinate investigations of deviations and complaints; manage GMP documentation and regulatory commitments.
• Contribute QA input to development plans and oversee qualification of CMOs, packagers, labs, vendors and supply chain partners.
• Support on-site activities at partner sites for manufacturing, packaging and labeling of IMPs as needed.

Skills

Quality Assurance

GMP/cGMP

Documentation

Root Cause Analysis

Data Integrity

Change Management

Analytical Skills

Communication Skills

Problem Solving

Technical Troubleshooting

Education

Bachelor's degree in Science/Engineering

Tools

Computer systems

Job description

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.

At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

Position Brand Description

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, 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

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.

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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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