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Our 35,000 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.
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Position Brand Description: The API EM Manager
– Quality Control provides analytical leadership for the API External Manufacturing (API EM) portfolio.
The Manager is responsible for leading scientists involved in technical and compliance aspects of analytical methods for API manufacturing at contract manufacturers (CMs) based upon sound scientific principles driving towards predictable and robust analytical methods and control strategies.
The Manager leads the technical staff responsible for the development and implementation of analytical methods and capabilities for continuous optimization and improvement with the CMs.
This includes workload planning, ensuring compliance of analytical methods with regulatory expectations, performance planning, coaching of team members, and overall customer service while developing employees.
It also includes day-to-day commercial portfolio support activities.
Key Objectives/Deliverables: Lead the API EM QC team, providing coaching / feedback to develop QC employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning Review and approve relevant technical documents, such as change controls, regulatory submissions, deviations, validations, procedures, APRs, PFDs, etc.
as applicable.
Consult on quality and stability issues within the API EM network of CMs, and act as a technical resource to guide the API EM QC staff Manage internal QC experimental projects to improve method performance robustness and overall analytical control strategies for the API EM portfolio Guide staff to ensure creation and maintenance of reference standards to support the API EM portfolio Maintain a technical understanding of the regulations applicable to laboratory testing in a cGMP environment Identify and resolve laboratory safety issues within the API EM laboratories Build working relationships with API EM technical leaders in QC, QA, and TS/MS, and with key internal and external partners Work closely with the API EM QC technical leadership to coordinate outsourced QC activities at CMs and external laboratory partners Minimum Requirements: Bachelor’s degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or a related Life Sciences field Minimum of five years of prior cGMP QC laboratory experience Demonstrated technical knowledge in laboratory analytical techniques, including, but not limited to, chromatographic, spectroscopic, and/or microbiological assays Thorough technical understanding of analytical laboratory compliance requirements and regulatory expectations Demonstrated strong problem-solving skills Strong verbal and written communication skills Demonstrated strong interpersonal interaction skills, with a proven ability to influence diverse groups and manage relationships Demonstrated leadership skills (decision making, prioritization, mentoring, conflict resolution) Previous experience and supervisory people and leading teams Additional Preferences: Advanced degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or related a Life Sciences field Demonstrated coaching and mentoring skills Demonstrated understanding of statistical tools and analysis Demonstrated flexibility when faced with changing priorities Strong attention to detail Strong self-motivation 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.
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As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.