Cell Therapy Process Optimization Specialist
7 days ago
Job Overview:
Omni Inclusive is seeking a highly skilled Cell Therapy Process Optimization Specialist to join our team. This individual will play a key role in ensuring the smooth operation of our manufacturing processes, focusing on process capability, compliance, and continuous improvement.
Responsibilities:
The ideal candidate will have expertise in biochemistry, chemical engineering, or cell biology, with experience in cellular therapies and regulated manufacturing environments. Key responsibilities include:
• Developing and revising process documents, study protocols, and technical reports to support technology transfer and process changes.
• Monitoring data from manufacturing processes to understand process capability and ensure they are operating within validated states.
• Supporting investigations into production-related issues, ensuring compliance with internal standards and regulatory requirements.
• Reviewing executed batch records to verify that processes are operating as expected.
• Managing tools and templates to quantify impact and criticality for parameters and attributes within client and/or CMO unit operations.
• Ensuring manufacturing processes are in a state of control, harmonized across the cell therapy network.
• Supporting continuous improvement initiatives for technical and business processes.
• Collaborating with external partners to leverage professional relationships and maintain compliance.
Requirements:
The successful candidate will possess a B.S. or M.S. degree in biochemistry, chemical engineering, or cell biology, with 4-7 years of relevant experience. Experience with JMP software and technical writing/deviation writing skills are preferred. Additionally, flexibility to work across East Coast and West Coast time zones and excellent communication, writing, organizational, teamwork, and presentation skills are essential.
Estimated Salary: $90,000 - $120,000 per year, depending on experience.
About Omni Inclusive:
Omni Inclusive is a leading provider of innovative solutions in the field of cell therapy. Our company values collaboration, innovation, and excellence, and we are committed to creating a workplace culture that supports the growth and development of our employees.
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