Process Expert

Role Summary

The Process Expert will provide front line support for all issues related to the manufacturing process, continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applicable guidelines and normatives. This role is located on-site in Morris Plains, NJ.

Responsibilities

• Provide front line technical and procedural support to manufacturing, working with the cell processing team, focusing on manufacturing each batch safely, on time, in compliance with the batch record and quality requirements.
• Provide latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs.
• Perform data analysis and identify potential process shifts/trends and escalate as necessary.
• Author investigations for product and non-product deviations.
• Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results.
• Work cross-functionally to assess deviation impact and identify root causes.
• Work with Scheduling and QA to ensure that batches are released on time through the closure of robust investigations and impact/risk assessments.
• Use process knowledge and root cause investigation tools to analyze data and identify the root causes of product and process failures.
• Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.
• Support escalation of deviations according to escalation guidelines, and present escalation events with deviation details clearly and on time (root cause and CAPAs).
• Identify opportunities for process, operational, and quality improvements in conjunction with the Manufacturing Team (PU) and Operational Excellence Team (OpEx).
• Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables.
• Evaluate manufacturing pre-production technical planning and review of technical data of incoming apheresis materials to ensure timely and required batch pathway processing by the manufacturing team.
• Provide timely updates to management on status of manufacturing performance and escalate potential performance issues to third parties.
• Provide timely support for process technology transfer activities from clients/third parties.
• Develop and provide training to the Cell Processing team as required, and own the Training Curriculum for this Job Profile; support new associates joining the Process Expert role and coach new investigators as part of the Investigator Certification Program.
• Maintain processes at inspection readiness level and provide support for internal or external audits, including authorities' inspections.

Qualifications

• 3+ years of relevant experience in pharmaceutical industry is required.
• Previous GxP experience is required.
• Excellent communication and collaboration skills.

Education

• Bachelor's degree in Science, Engineering or Biology or related field is required.