Senior Production Specialist Cell Suspension for Injection

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Senior Production Specialist Cell Suspension for Injection 

The Senior Production Specialist Cell Suspension for Injection is a subject matter expert (SME) responsible for clinical manufacturing of novel cell therapy drug substance and drug product within the Cell Therapy Module, CT-MOD. In this role you will Collaborate closely with biological development(BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment and will be a technical subject matter expert for aspects of the manufacturing process.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Production Specialist 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 is expected to work seamlessly across other areas as needed and will be an SME for multiple areas. Manufactures products in various phases of product life cycle from clinical through launch. Develops training materials for the CT-MOD team. Delivers training as an SME. Ensures own training is always in compliance. Modifies shift patterns & working hours if needed and at short notice to support CSI and surgical requirements;
• Builds new technical & business processes and/or drives the optimization of existing processes to increase efficiencies and meet business needs. Understands and manages processes related to documentation, sample handling, automation, cGMPs, etc. Trains and coaches team on new or optimized processes, equipment, procedures, etc;
• Participates as needed in ad-hoc project needs (continuous improvement, site priorities, etc.). May be dedicated to high-priority projects for extended periods of time. Leads manufacturing aspects of projects, including new product introductions (NPIs) into CCTC with support from biological development (BD), and tech transfer teams (MSAT). Collaborates with external & internal partners. Ensures activities are tracked and performed according to schedule;
• Manages, handles, and troubleshoots single-use technology (SUT) from end to end in the manufacturing process;
• Authors, reviews, and approves controlled documents. Ensures alignment with platform philosophy when appropriate. Assesses documentation impact of proposed changes in materials, and equipment and Key Tasks: provides decision-making recommendations for changes. Performs commissioning and IOPQ of equipment. Review, approve, and execute C&Q documentation;
• Monitors and controls aspects of manufacturing 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. Ability to make decisions independently where appropriate and/or with minimal supervision. Understand who relevant stakeholders are and seek input when needed;
• Raises and supports investigation of deviations. Partners cross[1]funct