Senior Engineer, MSAT

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

We are seeking a Senior Engineer or Scientist, Manufacturing Sciences & Technology to join our team. This is a full-time, onsite position based in Princeton, New Jersey, reporting to the AD, of MSAT.

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.

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.