Senior MSAT Engineer - Cell Therapy & GMP Transfer

MADE Scientific Inc; Princeton (NJ); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Made Scientific Inc. in Princeton, NJ, seeks a Senior Engineer or Scientist, Manufacturing Sciences & Technology, to drive technology transfer into the GMP facility.

You will execute upstream and downstream processing, perform analytical testing, and support cross-functional projects with strong experimental design and data analysis skills. The role emphasizes creating key documentation such as SOPs and Batch Records to ensure smooth process execution, with collaboration across MSAT, Project

Qualifications

• Knowledge of cell and gene therapy manufacturing concepts.
• Safety-first mindset and strict adherence to safety requirements.
• Ability to work independently with management oversight.
• Strong communication across cross-functional teams.
• Experience in GMP environments and regulatory filings (IND/NDA/BLA).

Responsabilités

• Support transfer of client processes into the GMP facility and scale-up.
• Design and execute upstream/downstream processing and testing.
• Draft and review CMC sections of IND filings and related docs.
• Perform analytical testing and process improvements with cross-functional teams.
• Prepare SOPs, Batch Records, specifications, and validation documents.

Connaissances

CMC knowledge

FDA regulations

Independent worker

Team collaboration

Communication skills

Self-starter

GMP familiarity

Process transfer

Analytical testing

Formation

M.S./Ph.D. in Molecular Biology or Biochemical/Biological Engineering

Description du poste

Made Scientific Inc. in Princeton, NJ, seeks a Senior Engineer or Scientist, Manufacturing Sciences & Technology, to drive technology transfer into the GMP facility.

You will execute upstream and downstream processing, perform analytical testing, and support cross-functional projects with strong experimental design and data analysis skills. The role emphasizes creating key documentation such as SOPs and Batch Records to ensure smooth process execution, with collaboration across MSAT, Project