Eli Lilly

Site Analytical Steward - QC

Eli Lilly$65K — $169K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related science field (e.g., chemistry, biochemistry, microbiology)
  • 3-5 years of relevant experience in a GMP lab
  • Proficiency in laboratory analysis techniques such as chromatographic and spectroscopic methods
  • Willingness to learn compliance and regulatory standards under mentorship
  • Strong problem-solving and analytical skills
  • Ability to work in a fast-paced startup environment
  • Good communication and interpersonal skills

Responsibilities

  • Provide analytical technical support for small molecule and oligonucleotide testing
  • Assist in the review of test data for batch release under supervision
  • Support investigations of out-of-spec results and perform root cause analysis
  • Contribute to regulatory reports and technical documentation
  • Participate in training of QC laboratory personnel
  • Help develop standard operating procedures and training materials
  • Ensure laboratory operations adhere to safety and compliance standards

Benefits

  • Participation in a company-sponsored 401(k) and pension plan
  • Vacation benefits and various leave of absence benefits
  • Eligibility for medical, dental, vision, and prescription drug benefits
  • Access to flexible spending accounts for healthcare and dependent care
  • Life insurance and death benefits
  • Well-being programs including employee assistance, fitness benefits, and social clubs
Full Job Description
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Position Overview: The Site Analytical Steward provides day-to-day analytical technical support for the Lilly Houston site as it stands up small molecule and oligonucleotide Drug Substance (DS) testing capability. Working under the technical mentorship of the Analytical Molecule Steward, this role performs hands-on laboratory problem solving, supports investigations of aberrant data and results, and helps build site analytical readiness across both modalities as equipment, methods, and staff come online. This is a developmental role: the Site Analytical Steward is expected to grow technical depth and independence over time, with the Analytical Molecule Steward providing structured mentorship, training, and oversight. As capability and experience develop, the Site Analytical Steward takes on increasing ownership of routine batch review, investigations, and method support activities at the Houston site. The Site Analytical Steward provides direct mentorship and coaching to QC analysts. The Site Analytical Steward reviews and supports interpretation of batch results for the laboratory and, as qualification develops, may support the holistic review of analytical results associated with a batch. The role works closely with the Analytical Molecule Steward, TS/MS, and process teams, and helps ensure the site technical agenda is executed at the working level. Key Objectives/Deliverables: Technical Review & Batch Support 3 Support technical review of individual test data associated with batch release, under the guidance of the Analytical Molecule Steward or other qualified reviewer. 3 As proficiency develops, take on increasing responsibility for review and release of routine batch and stability testing. Investigation Support 3 Support investigations into out-of-spec results and aberrant data, performing root cause analysis under mentorship. 3 Troubleshoot equipment and methods as required, escalating complex technical issues to the Analytical Molecule Steward. 3 Perform investigational testing as directed. 3 Interact effectively with business partners to communicate, resolve issues, and gain a clear understanding of each other's requirements. Continuous Improvement 3 Share technical information and contribute to regulatory and/or technical reports and memos. 3 Support research and evaluation of new technologies as the site builds out its equipment and method portfolio. Training & Development 3 Participate in structured technical mentoring provided by the Analytical Molecule Steward. 3 Support technical training of QC laboratory personnel as capability develops. Deviations & Change Controls 3 Support review of change controls and observations/deviations. 3 Document results of analyses and conclusions accurately and thoroughly in accordance with GMP and local guidelines. Site Readiness Support 3 Support laboratory operations in compliance with applicable procedures and standards as the site stands up. 3 Contribute to development of SOPs and training materials as needed. 3 Comply with safety standards and support safety programs within the laboratory. 3 Communicate effectively in both written and oral formats within the lab and with business partners. 3 Support protocol-driven studies (e.g., method validations, investigational studies, method transfers) under guidance. 3 Lead execution of equipment qualification and method transfer activities during site startup, in partnership with the Analytical Molecule Steward. Inspection Support 3 Support inspection readiness activities as directed. Method Support/Benchwork 3 Support Site Analytical Transfer Strategies for small molecule and/or oligonucleotide methods under mentorship. 3 Perform benchwork in support of method development, validation, and transfer activities. 3 Monitor method and process performance for assigned test areas. Basic Requirements: 3 Bachelor's degree in a science field related to the lab (e.g., chemistry, biochemistry, microbiology, or biology) and 3-5 years of relevant experience in a GMP lab. 3 Demonstrated proficiency or strong developing skill in laboratory analysis, including chromatographic, spectroscopic, and/or microbiological assays. 3 Ability to work in a lab environment, including wearing appropriate PPE and other safety equipment as required. 3 Developing understanding of compliance requirements and regulatory expectations, with willingness to build depth under mentorship. 3 Demonstrated problem-solving and analytical thinking skills. 3 Ability to focus on continuous improvement and to work effectively in a fast-moving site-startup environment. 3 Good interpersonal and communication skills; ability to receive and apply mentorship and feedback. 3 Proficiency with computer systems. 3 Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Preferences: 3 Exposure to small molecules, oligonucleotide, peptide, or protein analytical testing. 3 Familiarity with cGMP requirements in drug substance manufacturing. 3 Interest in growing into a more senior analytical steward role over time. 3 Experience or interest in supporting greenfield/startup site activities, including equipment qualification and method transfer. 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.

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
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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