Senior MSAT Scientist or Engineer

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

This role will support the transfer of client processes and technology in the Development space with the intent to enter our GMP facility, executing upstream and downstream processing, process optimization, and troubleshooting. They will conduct process and analytical testing, transfer processes for phase appropriate manufacturing and collaborate on cross-functional projects. Strong skills in experimental design, data analysis, and communication are essential. The role also involves maintaining customer relationships, supporting MSAT activities with Project Managers, and contributing to the creation of key documentation, including SOPs and Batch Records, to ensure smooth process execution.

This role will be primarily located in Princeton, NJ, fully onsite. However, the project responsibilities will require periodic travel to our other facility located in Newark, NJ (30%).

Key Responsibilities

• Strong Chemistry, Manufacturing, and Controls (CMC) knowledge in alignment with FDA regulations and remaining compliant with evolving regulations
• Knowledge of navigating the drug development process in terms of IND filings, NDA, amendments, and BLAs
• Ability to review, draft, and update CMC sections of IND filings
• Experience with FMEAs, gap assessments, APS and batch record authoring, process monitoring, and process improvements
• Design of manufacturing and test methods that endure drug safety, quality, and efficacy
• Assist with the assessment of client process, analytical, and material readiness for technology transfer activities into our GMP facility.
• Hands-on execution of the various aspects of processing and analytical activities to support small-scale studies and process scale-up.
• Design experiments for process optimization and troubleshooting.
• Implement solutions to technical issues and participate in continuous improvement activities.
• Complete analytical testing for development and technology transfer activities
• Extensive experience with experimental design, data analysis, organization, lifecycle management, and presentation of complex scientific concepts.
• Transfer processes from Development lab to the GMP facility for phase appropriate manufacture (early stage required, late stage preferred).
• Conduct work cross-functionally on a variety of projects.
• Communicate effectively with internal and external stakeholders, with ability to provide ad hoc clarification as needed.
• A high level of competence, integrity and communication
• Cleaning, organization, and residential maintenance of the laboratories as an active member executing experiments in the laboratory (e.g., weekly clean, inventory, etc.)
• Support creation of documents required for new process execution in Operations, SOPs, Batch Records, Specifications, Qualification and Validation requirements, etc.
• Performed other duties as assigned by Head of MSAT.

Required Qualifications

Preferred Qualifications

Required Degree(s)

Physical Requirements