Senior Principal Chemist

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Description:

We are seeking a skilled and motivated Senior Principal Chemist to become a member of the Pharmaceutical Investigations Team within the Global Quality Analytical Sciences and Quality Control Operations (AQCO) Team. This position provides independent analytical and technical support for multiple internal organizations including: manufacturing, quality, security, and legal. In this role, the Senior Principal Chemist will utilizes a variety of analytical techniques, instrumentation, and other available IT Tools and resources to analyze drug substances, drug products, and other non-typical samples/materials.  Analyses may involve physical and/or chemical evaluations of samples that include but are not limited to: foreign/unknown materials (trace analysis); samples suspected to involve counterfeiting, tampering, and/or diversion; product complaint investigations; and samples related to other technical projects supported by AQCO.

Key Objectives/Deliverables:

Analytical Testing, Data Documentation, and Technical Competency

·        Develops and independently executes complex protocols and procedures

·        Conducts isolation and identification of foreign/unknown materials (at times with short deadlines)

·        Conducts analyses of samples in support of legal initiatives (e.g., patent support)

·        Develops, optimizes, or streamlines analytical methods

·        Evaluates, develops, and implements new forensic and/or authentication technologies and methodologies

·        Willingness and aptitude to develop expertise in multiple analytical techniques (i.e., learning agility)

·        Utilizes good documentation practices and data integrity principles to generate accurate, on-time analytical data, technical reports, and other documentation

·        Performs second person verification, technical reviews, and data integrity reviews of other analysts’ data in accordance with GMP and data integrity requirements

·        Utilizes databases, tools, and software in support of analytical testing and business processes

·        Utilizes and manages confidential information in conducting investigations

·        Manages and communicates technical and non-technical information within the team and with cross-functional business partners/customers

·        Effectively communicates, both orally and written, with internal and external business partners

·        Proactively shares technical information across the organization 

·        Effectively works across global sites and cross-functional groups including but not limited to: manufacturing, quality, product and process development, analytical stewards, Global Packaging and Serialization, Global Security, legal, supply chain, and distribution

Laboratory Operations and Continuous Improvement Initiatives

·        Leads cross-functional, projects and initiatives

·        Supports equipment qualifications, calibrations, troubleshooting, and maintenance

·        Participates in local safety assessments and self-inspections

·        Supports local quality system improvements and implements solutions (e.g., SOP revisions)

·        Develops and administers training within the team and across the organization

·        Complies with laboratory safety standards, procedures, and requirements

·        Initiates change controls, observations, and deviations; supports root cause investigations

Influence and External Engagement

·        Influences peers, technical leaders, and management to accomplish obje