Production Specialist II Cell Culture Technology Center

 

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Production Specialist II Cell Culture Technology Center 

 

 

As the Production Specialist II Cell Culture Technology Center you will be responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.

  

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities for this role Production Specialist II Cell Culture Technology Center are to:

 

• Responsible for working across all areas and unit operations but maybe dedicated to specific operations as needed. Employee will be an SME for specific unit operation(s) and/or focused areas;
• Responsible for all tasks related to NPIs into CCTC that are relevant to their areas of focus. Ensures all activities are performed to schedule. Acts as delegate to Production specialist II;
• Collaborates with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for specific unit operation(s) and/or areas of focus;
• Manufactures products in various phases of product life cycles from clinical thru launch;
• Manages differences between multiple products. Ensures manufacturing is executed correctly regardless of product and/or life cycle phase;
• Operates the process using SUT from end to end. Troubleshoots single use technology (SUT) for their areas of focus;
• Retrieve, record, and analyze sample results to control processes;
• Monitors process using data trending for their areas of focus. Works cross functionally to ensure process is in control. Follows through to ensure all concerns are fully resolved;

• Redlines controlled documents for CCTC and incorporates stake-holders feedback. Reviews documents for their areas of focus and provides feedback to ensure alignment with platform philosophy for CCTC;
• Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally;
• Creates business processes in CCTC for their areas of focus to ensure manufacturing of products efficiently. Challenge status quo and provides continuous feedback for improvements;
• Supports investigation of deviations. Partners cross functionally to determine product impact and root cause. Executes manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence. Participates in regulatory and/or internal audits/walkthroughs. Acts as SME for their areas of focus;
• Performs commissioni