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 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
· 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
Additional Skills/Preferences:
· 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
Other Information:
Available to travel (domestic and international) on an average of <5%
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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
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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