investigation associate ms&t car-t.

- Lead multiple department manufacturing investigations as appropriate and/or establish strategy to quickly driving to root cause to meet critical release windows
- Oversee processes and standards and support the implementation of CAPAs
- Act as the company support for Regulatory Authorities inspection
- Build solid and long-lasting connections with different stakeholders
- Contribute to the strategic plan by building up scientific and cGMP specialist capability/expertis

Major Responsibilities:
Process Robustness
- Own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving
- Provide support and technical expertise to the Technical Operations team in support of ongoing technical transfer
- Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.

Quality & Compliance
- Apply and implement appropriate risk assessment methodologies and root cause analysis tools and assess product quality impact.
- Stay up to date with regulatory requirements and state of the art guidelines, maintain permanent inspection readiness, actively support regulatory inspections and preparation thereof as SME, and support the implementation of actions resulting from such inspections.
- Draft, feed, review/revise, and/or support writing of Investigations, Change Controls, C&Q protocols, technical assessments, SOPs and work instructions, Batch Records, potential compliance issues

Continuous Improvements

Development of partnerships in a matrixed environment