Associate Scientist - Cell Banking

As an Associate Scientist, you will perform cell banking operations to ensure master and working cell banks are manufactured to meet project timelines. You will also support mammalian and microbial cell banking programs within GMP Operations and at Contract Manufacturing Organizations (CMO), striving for right first time; GMP documentation management including but not limited to process transfer documents (PTDs), master batch records (MBRs), media forms, standard operating procedures (SOPs), work instructions (WIs), protocols and reports.

• Manufactures master and working cell banks to meet project timelines. Perform cell banking operations (manufacturing and stability assessments) following written procedures and master batch records in accordance with cGMPs. Duties include cell counts, cell passages, and environmental monitoring (EM).

• Supports the manufacture of cell banks at Contract Manufacturing Organizations (CMOs) including aspects of the process and material transfers.

• Completes and maintain all assigned/required safety and role-specific training.

• Represents the department on cross functional communications, meetings and on teams and coordinate activities, as required.

• Serves as equipment owner, coordinating tasks such as calibration scheduling, submitting Work Orders (WO), and addressing any Out of Tolerances/Out of Services (OOT/OOS), as required.

• Authors and executes documentation as applicable such as but not limited to, PTDs, MBRs, media forms, SOPs, WIs, and reports.

• For EM exceeded action limits (EALs), completes reviews to investigate possible root cause and complete necessary documentation.

• Coordinates and performs national and international cell bank shipments using liquid nitrogen shipper and evaluate temperature data post shipment for compliance.

• Maintains cell bank inventory, performs annual cell bank inventory checks, and supports transfer of cell banks to manufacturing, testing, and development groups.

• Participates in deviation investigations, implementation of Corrective and Preventative Actions (CAPAs) and Change Control (CC) actions, as required.

• Performs monthly, quarterly, bi-annual, yearly and changeover activities including but not limited to equipment cleaning, logbook reviews and historical data reviews.

• Supports preparation activities for GMP and safety audits, as required.

• BS in relevant field (Biology, Chemistry, etc.) and 1+ years of applicable working experience.

• Team player with ability to efficiently coordinate activities with others.

• Adhere to laboratory procedures and processes in completing routine tasks and respond quickly and appropriately to unanticipated events.

• Good communication skills.

• Strong work ethic and high level of personal efficiency.

• Knowledge of GMP requirements and documentation practices.

• General operational knowledge of laboratory/plant equipment.

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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