The Company
A global organization operating in advanced biopharmaceutical manufacturing, focused on innovative therapies and strict quality and compliance standards. The company supports cutting-edge production processes in highly regulated environments to deliver life-changing treatments.
Role Description
This role focuses on supporting manufacturing operations within the Manufacturing Science and Technology function. The position plays a key role in ensuring smooth commercial production of cell-based therapies while maintaining compliance with regulatory requirements.
You will be involved in process investigations, product release support, and continuous improvement initiatives while working closely with cross-functional teams.
Responsibilities
- Perform impact assessments to support product release activities
- Lead and support deviation investigations using root cause analysis methodologies
- Develop and manage corrective and preventive actions
- Collaborate with manufacturing, quality, and technical teams to resolve issues
- Author and review SOPs, batch records, and GMP documentation
- Support change control processes and process improvements
- Contribute to manufacturing projects and operational excellence
- Ensure compliance with regulatory standards and internal quality systems
Requirements
- Bachelor’s degree in biochemical engineering, chemical engineering, biotechnology, or related field
- Engineering background preferred
- Experience with cell culture, cell therapy, or aseptic manufacturing
- Strong knowledge of GMP and pharmaceutical manufacturing standards
- Hands-on experience with deviation investigations, root cause analysis, CAPA, and change control
- Experience in technical documentation and report writing
- Strong understanding of biopharmaceutical manufacturing processes
- Excellent communication and collaboration skills
Other Information
Department Manufacturing Science and Technology
Function Manufacturing Operations and Compliance Support
Work environment GMP regulated production setting
58423
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Mohammed Sarfaraz
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