Advisor - Forensic Science - Quality Control

Found in: beBee jobs US - 2 weeks ago


Indianapolis, Indiana, United States Eli Lilly and Company Full time

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:

The Global Quality Laboratories (GQL) – Advisor-QC (Forensic Scientist) is a member of the Pharmaceutical Investigations Team within the Global Quality Laboratories organization. This position provides independent analytical and technical support, utilizing a variety of analytical techniques, instrumentation, and other available IT Tools and resources, for 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: identification/characterization of foreign or unknown materials; product complaint investigations; patent support (legal); samples suspected to involve counterfeiting, tampering, and/or diversion; and samples related to other technically complex projects supported by GQL. The GQL Forensic Scientist provides global, strategic, and technical leadership, influences the local technical agenda, and mentors other chemists (within and outside of GQL).

Key Objectives/Deliverables:

Analytical Testing, Data Documentation, and Technical Competency

Develops and executes complex protocols and procedures.Develops, optimizes, or streamlines analytical methods across multiple technologies and instrument types.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)Evaluates, develops, and implements new 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 partnersProactively 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 InitiativesLeads larger-scale, cross-functional, projects and initiatives.Supports equipment evaluations, 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.Mentoring, Influence, and External EngagementParticipates in and/or leads external groups, forums, and conferences to maintain awareness of industry trends and to develop / maintain external network.Influences peers, technical leaders, and management to accomplish objectives and promote process improvements.Mentors other analysts within and/or outside of the team.Basic Qualifications: The GQL Forensic Scientist is expected to have knowledge and technical skills necessary to successfully lead GQL through complex projects. The GQL Forensic Scientist must have strong relationship and communication skills and an ability to influence team members, leadership, and cross-functional teams. Bachelor of Science degree (4-year college) or Master's degree in chemistry, biochemistry, forensics (or related scientific field) or equivalent work experience.Current experience working in an analytical testing laboratory environment.Minimum of 10 years of experience in conducting forensic analyses or related workMust 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 ability to effectively operate in a fast-paced, highly dynamic environment with frequently changing priorities.Additional Skills/Preferences:Experience in a variety of physical and chemical analytical techniques/methodologies including data interpretation (e.g., HPLC, GC/MS, IR, NIR, Raman, laser diffraction, surface area, moisture sorption, x-ray powder diffraction, particle size, TGA, DSC, SEM/EDS, Optical Microscopy, etc.)Experience in providing expert witness testimony in a court of law.Experience with good documentation practices (i.e., ALCOA Principles) and technical writing.Knowledge of current Good Manufacturing Practices (cGMPs)Experience with handling Controlled SubstancesDemonstrated organizational skills.Experience with handling/communicating confidential information.Demonstrated strong written and oral communication.Fundamental knowledge of cGMP/GLP compliance requirementsAbility to testify in a court of law (globally), as necessary.Other Information: Available to travel (domestic and international) on an average of
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