Scientist I

Job Description

Responsibilities

• Perform laboratory work in accordance with protocols, methods, and requirements in a GMP laboratory setting.
• Perform routine cell maintenance and cell banking of various mammalian, avian, and insect cell lines. Project cell culture needs for scheduled testing and expand accordingly. • Independently execute GMP testing and report data in LIMS.
• Perform analytical method development and qualification, and write and review associated documents in compliance with regulatory guidelines.
• Assist in the troubleshooting and optimization of assays when required.
• Perform and document reagent qualifications.
• Perform and document hands-on training for other team members in areas of proven competency.
• Write and own compliance events, including laboratory investigations, deviations, and change controls.
• Coordinate with Supply Chain and warehouse to order, track, and maintain lab supplies and inventory. Author material specification forms for new items when required.
• Additional duties as assigned.