We are looking for Process Experts to join a dynamic team focused on the manufacturing of advanced therapies. In this role, you will serve as a subject matter expert (SME) on manufacturing processes, providing essential support to ensure therapies are delivered on time for clinical trials. Your focus will be on continuous process improvement while maintaining compliance with GMP standards.
This is an exciting opportunity to join a newly established MSAT team in response to increasing production demands. You will be responsible for ensuring that all processes are followed, troubleshooting when necessary, and driving improvements to enhance overall quality and productivity.
Key Responsibilities:
* Act as an SME in manufacturing processes, ensuring timely production in line with SOPs and GMP standards.
* Lead troubleshooting efforts for complex manufacturing issues.
* Manage deviation investigations and implement corrective and preventive actions (CAPAs).
* Monitor processes during manufacturing to ensure compliance with critical parameters and GMP.
* Collaborate with Tech Transfer teams to ensure smooth process transitions while maintaining GMP compliance.
* Drive process improvements to enhance operational efficiency and product quality.
Desired Skills and Experience:
* Proven experience in the Biotech, Biopharmaceutical, or Biologics industries.
* Expertise in GMP and compliance standards.
* Experience in an MSAT, Process Expert, or similar role.
* Familiarity with clean room or aseptic techniques.
* Experience with technical transfer processes.
* ATMP (Advanced Therapy Medicinal Products) manufacturing experience is a plus but not required.
About the Role:
This is a fantastic opportunity to contribute to the advancement of cutting-edge therapies that can make a meaningful impact on patients' lives. If you're passionate about process optimization, quality control, and working in a fast-paced environment, we encourage you to apply.
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