Eli Lilly

Analytical Technical Steward-Small Molecule

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

  • Bachelor's degree in a science field (Chemistry, Biochemistry, Pharmacy)
  • 5+ years in a GMP lab within pharmaceuticals
  • Proficiency in complex laboratory analyses (HPLC, GC, etc.)
  • Understanding of compliance and regulatory expectations
  • Experience with method qualification, validation, and transfer

Responsibilities

  • Review and release technical data from contract manufacturers and stability studies
  • Lead investigations into out-of-specification results
  • Develop testing protocols and oversee compliance testing
  • Contribute to AP reports, tech transfers, and process validation
  • Coordinate testing needs across multiple sites for batch release and stability

Benefits

  • Participation in company-sponsored 401(k) and pension plans
  • Comprehensive health benefits including medical, dental, and vision
  • Flexible spending accounts for healthcare and dependent care
  • Life insurance and death benefits
  • Employee assistance and wellness programs
Full Job Description
The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. This position will be small molecule focused. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development and global labs counterparts to ensure robust analytical control strategies are established for molecules they support.

Responsibilities:
  • Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization.
  • Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
  • Develop investigational testing protocols and perform or oversee testing as required.
  • Contribute to APR, tech transfer, and process validation as required.
  • Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners.
  • Participate in internal/external audits as needed.
  • Develop and ensure execution of quality plan projects.
  • Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
  • Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
  • Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed.
  • Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices).
  • Review of analytical test method packages.
  • Approval of test method protocols.
  • Approval of new test methods or changes or deletions to existing test methods.
  • Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions).
  • Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies.
  • Improve assays in QC. These improvements include variability reduction, method optimization, and new method development.
  • Local and Global Method Change Control Ownership.
  • Oversight of reference standard evaluations per Global Quality Standards.
  • Consult in the preparation of the characterization protocol for corporate reference standards.
  • Participate in the review of the reference standard profile and associated documentation for data integrity.
  • Method transfers to Contract Manufacturers.
  • Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs.
  • Monograph review and implementation.
  • Ensures consistent practices between laboratories running the same methods.
  • Effective management of multiple projects.


Basic Requirements:
  • Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy)
  • 5+ years of industry related experience in pharmaceuticals in a GMP lab
  • 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 Skills/Preferences:
  • Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, KF, particle size, LOD, appearance, compendial tests, etc.
  • Deep understanding of compliance requirements and regulatory expectations, including principles of ALCOA++ and data integrity.
  • Demonstrated accuracy and proficiency in analytical skills.
  • Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology.
  • Strong oral and written communication skills demonstrated through documentation and presentations.
  • Demonstrated strong interpersonal interaction skills.
  • Ability to work in cross functional teams as well as across networks.
  • Demonstrated analytical skills.
  • Demonstrated experience with method qualification, validation, and transfer.
  • Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs on small molecule platform
  • Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV).
  • Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers.


Additional Information:
  • Position will be day shift, but may require some shift to support global operations
  • May require up to approximately 20% of travel overseas, passport required

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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