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Process Data Analyst-FDE

Branchburg Township, New Jersey

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Req ID 55061 Title Process Data Analyst-FDE City Branchburg Park State / Province New Jersey Country United States Region North America

Company Overview

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 39,000 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. 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. #WeAreLilly

Responsibilities

This position is responsible for ensuring the accuracy of data and providing data analysis support for data generated during manufacturing processing. This position will interact with the manufacturing, quality assurance and quality control departments. Some interaction with other Lilly sites or contract manufacturers may be required. Knowledge of cell culture, purification and support systems is a plus. Spreadsheet experience required, database experience a plus.
Primary Responsibilities:

  1. Verifies the accuracy of the data entered into the in-process database by the operations staff and ensures that all the data entries are complete.

  2. Assists with the trending and analysis of manufacturing production data to support: deviations, process validation protocols and reports, technology transfer documentation, BLA filings, annual manufacturing summaries for regulatory documentation, etc.

  3. Assists with the maintenance of local databases.

  4. When requested, provides data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending.

  5. May lead small to medium-scale projects or programs. Makes decisions that impact own priorities and allocation of time to meet deadlines.

  6. Provides sound problem solving skills to complex issues.

  7. Writes SOPs as they relate to the activities of the TS/MS group. May assist with SOPs from other manufacturing groups.

  8. Understands and performs all job responsibilities in compliance with safety and regulatory expectations, as well as, cGMP.

55061BR

Basic Qualifications

  • B.S. in a scientific or engineering discipline

Additional Skills/Preferences

  • Experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment

  • ​Strong mathematical and analytical skills

  • WORD, EXCEL, and Powerpoint experience required, coding experience a plus

  • SQL database experience a plus

  • Experience in cell culture and/or protein purification manufacturing a plus

  • An understanding of current Good Manufacturing Practices a plus.

  • Excellent communication skills, both oral and written

  • Familiarity with TrackWise and LIMS a plus

Additional Information

  • This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.

  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID 55061.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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