GMP Process Investigator

We are currently looking for a GMP Process Investigator (Scientific Documentation Specialist) within Manufacturing Excellence CAR-T EMEA. The MSAT CAR-T EMEA organization provides and supports a high degree of assurance that specific processes will consistently produce and meet predetermined specifications by deploying process validation, process system engineering, data architecture, continuous process verification, and process investigation.

Key Responsibilities:

The Process Investigator is responsible for providing quality investigation insights into the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes assessing process information, reviewing in-the-field manufacturing investigations, following up on various departmental post-implementation optimizations, and tracking quality metrics while ensuring a high-quality and compliant product supply. You will be:

• Collaborating with manufacturing teams to provide guidance and determine resolution for manufacturing issues/deviations.
• Ensuring accurate and timely reviews of manufacturing investigations, CAPAs, change controls and complaints.
• Demonstrating detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to cell-based product manufacturing or cell processing.
• Performing analysis on quality indicating data and identifying trends.
• Collaborating with functional departments to resolve issues.
• Contributing to cross-functional projects/teams with many stakeholders.
• Performing tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Providing guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
• Driving continuous quality improvements.

Requirements

• A bachelor’s degree in molecular biology, cell biology, biochemistry, or related area in the Life Sciences is required. A master’s degree is a plus.
• Strong working knowledge of current Good Manufacturing Practices (cGMP).
• Experience working in a controlled, cleanroom environment under aseptic conditions is required.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Highly organized with the ability to pay attention to details and follow procedures.
• Fluent communication skills in English.
• Proficient in using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).