Senior Principal Chemist Jobs

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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

The Senior Principal Chemist is a member of the Pharmaceutical Investigations Team within the Global Quality Laboratories (GQL) organization. This position provides independent analytical and technical support for multiple internal organizations including: manufacturing, quality, security, and legal. The Senior Principal Chemist 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 projects supported by the Global Quality Laboratories’ Analytical Sciences team.

Key Objectives/Deliverables

Analytical Testing, Data Documentation, and Technical Competency

• Effectively communicates, both orally and written, with internal and external business partners
• Develops and independently executes complex protocols and procedures
• 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.
• Develops, optimizes, or streamlines analytical methods
• Utilizes and manages confidential information in conducting investigations
• Conducts authentication of suspect packaging, products, and other materials
• Utilizes databases, tools, and software in support of analytical testing and business processes
• Utilizes good documentation practices and data integrity principles to generate accurate, on-time analytical data, technical reports, and other documentation
• 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)
• Manages and communicates technical and non-technical information within the team and with cross-functional business partners/customers
• Performs second person verification, technical reviews, and data integrity reviews of other analysts’ data in accordance with GMP and data integrity requirements.
• Evaluates, develops, and implements new forensic and/or authentication technologies and methodologies
• Proactively shares technical information across the organization

Laboratory Operations and Continuous Improvement Initiatives

• Leads cross-functional, projects and initiatives
• Complies with laboratory safety standards, procedures, and requirements
• Supports local quality system improvements and implements solutions (e.g., SOP revisions)
• Conducts equipment qualifications, calibrations, troubleshooting, and maintenance
• Participates in local safety assessments and self-inspections
• Initiates change controls, observations, and deviations; supports root cause investigations
• Develops and administers training within the team and across the organization

Influence and External Engagement

• Influences peers, technical leaders, and management to accomplish objectives and promote process improvements
• Participates in and/or leads external groups, forums, and conferences to maintain awareness of industry trends and to develop / maintain external network

Basic Qualifications

• Bachelor of Science degree (4-year college) or Master’s degree in forensics, chemistry, biochemistry (or related scientific field) or equivalent work experience
• Experience in working in a forensic laboratory, conducting forensic analyses of unknown/foreign materials
• Experience in physical and chemical analytical techniques/methodologies including data interpretation (e.g., HPLC, GC/MS, IR, NIR, Raman, SEM/EDS, Optical Microscopy, etc.)
• Experience in providing Expert Witness testimony and ability to testify in a court of law (globally)
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
• Ability to work in a lab environment, including wearing appropriate PPE, standing for extended periods of time, lifting objects < 20lbs, handling organic solvents (some hazardous) and handling PHMs
• Must be able to be authorized to handle Controlled Substances, as necessary

Additional Skills/Preferences

• Experience with handling/communicating confidential information
• Fundamental knowledge of cGMP/GLP compliance requirements
• Demonstrated ability to effectively operate in a fast-paced, highly dynamic environment with changing priorities
• Ability to effectively multitask, prioritize, and handle ambiguity
• Demonstrated strong written and oral communication
• Experience with handling Controlled Substances
• Experience with good documentation practices (i.e., ALCOA Principles) and technical writing
• Demonstrated organizational skills
• Experience working in a Good Manufacturing Practices (GMP) environment

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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