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
The Director of Manufacturing Science & Technology (MSAT) will lead the technical oversight, process lifecycle management, and technology transfer activities for cell therapy manufacturing programs within a CDMO environment. This role is responsible for ensuring robust, scalable, and compliant manufacturing processes for autologous and allogeneic cell therapy products from clinical development through commercial manufacturing.
The Director will work cross-functionally with Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and Client Program teams to support client programs, drive continuous process improvement, and ensure successful technology transfers into GMP manufacturing.
This role is based in Princeton, NJ and is fully onsite.
Key Responsibilities
• Provide scientific and technical leadership for 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.
• Lead troubleshooting efforts and root cause analysis for manufacturing deviations, investigations, and CAPAs.
• Drive implementation of process monitoring and control strategies.
• Lead technology transfer activities from clients or internal process 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 for manufacturing processes.
• Lead process characterization, comparability studies, and validation support activities.
• Provide real-time technical support to GMP manufacturing operations for clinical and commercial 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 client programs.
• Ensure MSAT activities comply with cGMP, FDA, EMA, and ICH regulatory requirements.
• Contribute to regulatory filings, including INDs, BLAs, and comparability packages.
• Support regulatory inspections and client audits.
• Build and lead a high-performing MSAT team, including scientists and engineers.
• Provide mentorship, technical guidance, and performance management.
• Develop MSAT strategy aligned with organizational growth and client pipeline.
• Perform other duties as assigned by the Head of Development.
Required Qualifications
• PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or a related field.
• 10–15+ years of experience in biopharmaceutical manufacturing or process development.
• 5+ years of leadership experience in MSAT, technical operations, or process development.
• Strong experience in cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).
• Experience working within a CDMO environment strongly preferred.
• Deep knowledge of:
• Cell culture and 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 analytics tools.
• Strong cross-functional leadership and project management skills.
• Experience working directly with biotech clients.
• Excellent written and verbal communication skills.
• Ability to operate in a fast-paced CDMO environment supporting multiple client programs.
Preferred Qualifications
• Experience with commercial cell therapy manufacturing.
• Experience with automated manufacturing platforms (e.g., CliniMACS Prodigy, Lonza Cocoon).
• Knowledge of viral vector manufacturing processes.
• Experience supporting BLA submissions or late-stage clinical programs.
Physical Requirements
• Ability to perform essential job functions in compliance with ADA, FMLA, and other 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.