Analyst-Process Sciences-FDE

Company Name:
Eli Lilly
Company Overview:
ImClone Systems LLC is a leader in therapeutic monoclonal antibodies and committed to changing the world of cancer care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of tumor types. Founded in 1984, ImClone has a rich culture of discovery and deep expertise in oncology. Following its acquisition by Eli Lilly and Company in 2008, ImClone is accelerating its antibody pipeline development by leveraging Lilly's global capabilities. ImClone's pipeline has several molecules in mid- to late-stage clinical development targeting a variety of cancers.
Responsibilities:
Responsible for supporting manufacturing operations through the performance of the following duties:
Verifies the accuracy of the data entered into the in-process database by the operations staff and ensures that all of the data entries are complete.
Assists with the trending and analysis of manufacturing production data to support: Non-Conformance Events, process validation protocols and reports, comparability and consistency protocols and reports, technology transfer documentation, BLA filings, annual manufacturing summaries for regulatory documentation, etc.
Assists with the maintenance of the manufacturing in-process database.
When requested, provides in-process data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending.
Performs all job responsibilities in compliance with current Good Manufacturing Practices.
Basic Qualifications:
B.S. degree in a scientific discipline or equivalent skills and relevant experience.
Minimum 0-2 years experience in a GMP production/development environment.
Qualified candidate 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 position.
Additional Skills/Preferences:
Experience in fermentation/cell culture and/or protein purification manufacturing a plus.
An understanding of current Good Manufacturing Practices a plus.
Strong mathematical and analytical skills.
WORD and EXCEL experience required; PowerPoint, JMP and VISIO experience a plus.
Database experience a plus
Excellent communication skills, both oral and written.
Additional Information:
This position is not permanent. It is for a fixed duration for up to 4 years.
Eli Lilly and Company, Lilly USA LLC, affiliates and our wholly owned subsidiaries including ImClone Systems (collectively, Lilly) are EEO/Affirmative Action Employers, and do not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
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