Production Specialist III Cell Suspension for Injection

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Production Specialist III Cell Suspension for Injection 

Responsible for clinical manufacturing of novel cell therapy drug substance and drug product within the Cell Therapy Module, CT-MOD. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment. Works with various aspects of the CSI and/or Da01 process from expansion through differentiation and fill/finish.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Production Specialist III- Cell Suspension for Injection, are to:

• Responsible for manufacturing in the assigned area which may include, but is not limited to, Solution Preparation, Cell Expansion & Differentiation, Cell Suspension for Injection (CSI), Cell Banking, Drug Product Filling, and Packaging. Primarily assigned to CSI activities,but expected to work across other areas including Da01. Will be an SME for an aspect of the manufacturing process including equipment. Handles and troubleshoots single-use technology (SUT) from end to end in the manufacturing process;
• Manufactures products in various phases of product life cycles from clinical through launch. Develop training curricula and training materials for the CT-MOD team. Delivers training. Ensures own training is always in compliance. Modifies shift patterns & working hours when needed and at short notice to support CSI and surgical requirements;
• Participates as needed in ad-hoc project needs (continuous improvement, site priorities, etc.). May be dedicated to projects when needed.
• Owns and drives manufacturing aspects of projects, including new product introductions (NPIs) into CCTC with support from biologicaldevelopment (BD), and tech transfer teams (MSAT). Collaborates with external & internal partners. Ensures activities are tracked and performed according to schedule; 
• Supports the need to drive the optimization of existing processes to increase efficiencies and meet business needs. Actively looks for opportunities to improve. Creates business processes of moderate complexity. Understand processes related to documentation, sample handling, automation, cGMPs, etc. Trains team on new or optimized processes, equipment, procedures, etc;
• Authors, reviews, and approves controlled documents. Ensures alignment with platform philosophy when appropriate; Assesses owndocumentation for impact when changes in materials & equipment are proposed and provides decision-making recommendations for changes. Performs commissioning and IOPQ of equipment. Review, approve, and execute C&Q documentation;
• Monitors and controls processes using data trending and/or statistical process control where relevant. Works cross-functionally to ensure the process is controlled and issues are escalated and investigated;
• Raises and supports investigation of deviations. Partners cross-functionally to determine product impact and root cause. Owns and implements effective corre