What are the responsibilities and job description for the Engineer/Scientist MSAT position at Made Scientific?
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. 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
Made Scientific’s engineers, operations, and quality professionals work with clients to translate groundbreaking treatments into the clinic. The novel therapeutics we support require constant innovation and creative thinking to enable successful clinical translation and GMP manufacturing. Our state-of-the-art Princeton, NJ facility includes both development labs and cleanroom space to support clinical manufacturing. This role supports the transfer of client processes and technologies from development into GMP manufacturing. The position involves executing upstream and downstream processing, process optimization, and troubleshooting, as well as conducting process and analytical testing. This individual will support Phase I/II manufacturing, collaborate cross-functionally, and contribute to key documentation such as SOPs and batch records to ensure smooth process execution. This role is based in Princeton, NJ and is fully onsite.
Key Responsibilities
• Provide scientific and technical ownership of cell therapy manufacturing processes, including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.
• Serve as the technical subject matter expert (SME) for manufacturing processes supporting client programs.
• Drive troubleshooting and root cause analysis for manufacturing deviations, investigations, and CAPAs.
• Implement process monitoring and control strategies to ensure process consistency and compliance.
• Lead technology transfer activities from clients or internal development teams into GMP manufacturing.
• Develop and review technology transfer plans, process descriptions, risk assessments, and gap analyses.
• Ensure successful scale-up and scale-out of manufacturing processes across CDMO facilities, as applicable.
• Oversee continued process verification (CPV) and lifecycle management of manufacturing processes.
• Lead process characterization, comparability studies, and validation support activities.
• Provide real-time support to GMP manufacturing operations for clinical batches.
• Review batch records, deviations, and change controls related to process changes.
• Present technical updates during client meetings and governance reviews.
• Support proposal development, technical due diligence, and onboarding of new programs.
Required Qualifications
• Degree in Molecular Biology, Chemical, Biochemical, or Biological Engineering, Biochemistry, Biotechnology, or a related field.
• 2–15 years of experience in biopharmaceutical manufacturing or process development.
• Strong experience in cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).
• Deep knowledge of:
• Cell culture and cell expansion technologies
• Viral vector transduction or gene editing workflows
• Closed and automated cell therapy manufacturing platforms
• Cryopreservation and fill-finish processes
• Experience with technology transfer, process validation, and process characterization.
• Familiarity with statistical process monitoring and data analysis tools.
• Excellent written and verbal communication skills.
• Ability to operate in a fast-paced CDMO environment supporting multiple client programs.
Preferred Qualifications
• Experience working in a CDMO environment.
• Experience with commercial cell therapy manufacturing.
• Experience with automated manufacturing platforms (e.g., CliniMACS Prodigy, Lonza Cocoon).
• Knowledge of viral vector manufacturing.
• Experience supporting BLA submissions or late-stage clinical programs.
Physical Requirements
• Ability to perform essential job functions in compliance with ADA, FMLA, and applicable regulations, including meeting productivity standards.
• Ability to maintain regular and punctual attendance.
• Must be willing to become gown-qualified and work in BSL-2 lab, CNC, ISO7, and ISO8 environments.
• Ability to lift and carry up to 30 lbs.
• Ability to bend, stoop, reach, climb, and stand on elevated surfaces as needed.
• Ability to sit or stand for extended periods.
• Must be comfortable working with cell-based products, chemicals, or hazardous materials.