Sr Principal Chemist- Product Protection

Organization /

Position Overview:

The Global Analytical Sciences and Quality Control Operations (AQCO) organization 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 Sr. Principal Chemist 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 a variety of analytical techniques/instrumentation (e.g., HPLC, UPLC, Spectroscopy, etc.). 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, sRNAs, gene therapy and drug conjugates. The Sr. Principal Chemist 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.

• Perform analyses of suspect products using LC-MS (including intact mass and peptide mapping), HPLC, UPLC, spectroscopy and other analytical techniques.
• Analyze LC-MS data and perform limited structure elucidation on both small and large molecules
• Provide non-laboratory support for other product authentication processes (e.g., packaging authentication, packaging variable data verification, etc.)
• 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
• 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.

• Deep technical expertise in separation sciences, spectroscopy, hyphenated mass spectrometry techniques (MS and MSn.) and their application
• Demonstrated proficiency in the use of multiple instrument platforms (Thermo, Agilent, Waters etc.) and associated software platforms (Chromeleon, Excalibur, Biopharma Finder, Genedata, 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.

• Minimum B.S. in Analytical Chemistry or related scientific field
• 5+ years of recent bench experience in a laboratory environment, relating to mass spectrometry.

• Ability to perform structure elucidation on both small and large molecules.
• Knowledge of Lilly systems such as NuGenesis (eLN), Quality Docs, SAP, Smart Lab, etc.
• Strong written and oral communication skills
• Ability to work independently, self-sufficiently and proactively 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…