Eli Lilly

Principal Scientist QA

Eli Lilly • $65K — $169K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5-7 years of professional experience in quality assurance or related fields.
  • Strong understanding of global clinical trial cGMP regulations.
  • Experience in at least two areas: API, drug product manufacturing, clinical trial packaging, analytical labs, or ADC.
  • Background in Large Molecule manufacturing and Antibody Drug Conjugation is preferred.
  • Proficient in relevant computer systems and data handling.
  • Exceptional oral and written communication skills.

Responsibilities

  • Support the delivery of pre-commercialization materials ensuring consistent quality compliance.
  • Execute and maintain Early Phase Quality Systems to meet regulatory standards.
  • Review and approve documentation for manufacturing activities and clinical trial materials.
  • Oversee deviation and complaint investigations for quality assurance.
  • Collaborate with internal teams to ensure compliance in early phase operations.
  • Provide onsite support for manufacturing and packaging at partner facilities.
  • Identify and implement continuous improvement opportunities in quality processes.

Benefits

  • Participation in a company-sponsored 401(k) and pension plan.
  • Comprehensive medical, dental, vision, and prescription benefits.
  • Flexible benefits including healthcare and dependent care accounts.
  • Well-being programs such as employee assistance and fitness benefits.
  • Generous vacation and leave of absence policies.
Full Job Description
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.

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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