Senior Principal Chemist

Eli Lilly and Company • Us, IN

1d • Onsite

About The Position

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.

Requirements

• Bachelor of Science degree (4-year college) or Master’s degree in forensics, chemistry, biochemistry (or related scientific field) or equivalent work experience
• Current experience in working in an analytical testing laboratory environment with a minimum of 5 years of experience
• Hands-on experience in physical and chemical analytical techniques/methodologies including data interpretation (e.g., HPLC, GC/MS, IR, NIR, Raman, SEM/EDS, Optical Microscopy, etc.)
• Must be able to be authorized to handle Controlled Substances, as necessary
• 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
• Demonstrated strong written and oral communication
• Demonstrated ability to effectively operate in a fast-paced, highly dynamic environment with frequently changing priorities
• Ability to effectively multitask, prioritize, and handle ambiguity
• Capability to build strong relationships and communication skills and an ability to influence team members, leadership, and cross-functional teams.
• 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

Nice To Haves

• Experience with good documentation practices (i.e., ALCOA+ Principles) and technical writing
• Working knowledge and experience operating in a GMP-regulated laboratory environment.
• Fundamental knowledge of GLP compliance requirements
• Experience with handling Controlled Substances
• Demonstrated organizational skills
• Experience with handling/communicating confidential information
• Willingness to develop capability and skill in expert witness testimony

Responsibilities

• 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
• 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
• 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
• 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

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees