At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$121,500 - $198,000

Organization/Position Overview:

The Global Analytical Sciences and Quality Control Operations or “AQCO” organization (formerly the Global Quality Laboratories) resides within Central Quality. AQCO is responsible for providing quality, scientific, and process leadership to support: global functions, internal and external business partners, and regulatory authorities. AQCO aids in problem-solving, developing sustainable control strategies, influencing operational excellence, and defining and/or replicating quality best practices.

• The Analytical Scientist Advisor (Advisor) is a member of AQCO’s Analytical Sciences Team and will have a primary responsibility for conducting non-routine analyses of drug substances, drug products, and other non-typical samples suspected to involve counterfeiting, tampering, or diversion using advanced analytical mass spectrometry. As required, the Advisor may also utilize other analytical techniques (e.g., HPLC, UPLC, Spectroscopic techniques, etc.) to support product investigations. Samples associated with these investigations may originate from: product complaints, proactive surveillance (by Lilly security and/or legal), or global law enforcement/government agencies. Sample types include but are not limited to: small molecules, peptides, therapeutic proteins, s RNAs, gene therapy and drug conjugates. The Advisor will also contribute to developing advanced authentication strategies/analytical techniques for pipeline assets. As the Pharmaceutical Investigations Team expands its capacity and capabilities due to increased sample volumes (primarily anti-obesity medications), this position will help to ensure that samples are investigated and reported in a timely manner, thereby supporting cross-functional business partners and Lilly’s overall product protection strategy.

Given the increasing need for more in-depth molecule information and the increasing complexity of assets, the Advisor will also support characterization initiatives (using LC-MS) in support of manufacturing objectives.

Key Responsibilities:

Pharmaceutical Investigations Team Support:

• Perform LC-MS analyses (including intact mass and peptide mapping) of samples suspected to involve counterfeiting, tampering, or diversion

• Analyze LC-MS data and perform limited structure elucidation on both small and large molecules

• Collaborate with AQCO colleagues and other analytical SMEs to solve complex sample analyses

• Support special studies proposed by business partners (e.g., Global Security, Legal)

• Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.

• Actively participate in mass spectrometry community / forums to maintain proficiency and expertise

• Troubleshoot issues with methods and/or equipment

Analytical Sciences Support:

• Support the technical agenda for pipeline and commercial assets.

• Execute testing protocols in accordance with local procedure and regulatory requirements.

• As required, provide training or mentorship to other AQCO colleagues or cross functional team members.

Job specific pre-requisites:

Deep technical expertise in separation sciences, spectroscopy, hyphenated mass spectrometry techniques (MS and MS n .) and their application

• Demonstrated proficiency in the use of multiple instrument platforms (Thermo, Agilent, Waters etc.) and associated software platforms (Chromeleon, Excalibur, Biopharma Finder, etc.)

• Ability to handle controlled substances

• Ability to work with non-technical personnel

• Ability to manage/communicate confidential information

• Strong technical problem-solving ability both independently and as part of a team.

• Motivated to work independently to produce high quality work product in an efficient manner.

• High attention to detail in all aspects of the work.

Basic Requirements

• Minimum B.S. in Analytical Chemistry or related scientific field

• 3+ years of recent bench experience in a laboratory environment, relating to mass spectrometry.

Additional Skills/Preferences:

• Ability to perform structure elucidation on both small and large molecules

• Knowledge of Lilly systems such as Nu Genesis (e LN), Quality Docs, SAP, Smart Lab, etc.

• Strong written and oral communication skills

• Ability to work independently, self-sufficiently and pro-actively in the performance of work duties.

• Ability to resolve conflict and promote good decision making among team members.

• High learning agility and flexibility to achieve the required outcomes.

• Working knowledge in one or more of the following chemical, peptide or protein synthesis

• Imaginative approach to problem solving and solution discovery.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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