MSAT Global Head: Cell & Gene Manufacturing Excellence

Minaris Regenerative Medicine Co., Ltd.; Allendale (NJ); Remote; USD 250,000 - 350,000; Full time

Job summary

Minaris Regenerative Medicine Co., Ltd. is seeking a senior MSAT leader to oversee clinical and commercial manufacturing support, technology transfer, and lifecycle management across the Minaris network.

The role requires extensive experience in cell and gene therapy manufacturing, validated leadership, and a strategic focus on risk-based decision making, process optimization, and client delivery. This position may offer remote work options and frequent cross-site collaboration.

Qualifications

• Deep knowledge of biopharmaceutical manufacturing processes, preferably cell therapy or gene therapy.
• Strong understanding of GMP regulations, ICH guidelines, FDA/EMA expectations, and validation lifecycle principles.
• Expertise in technology transfer, comparability strategy, PPQ, CPV, and lifecycle process management.
• Proven experience delivering client programs and supporting commercial manufacturing expansion.

Responsibilities

• Provide strategic leadership for the MSAT organization and align priorities with business strategy.
• Lead technical input for new opportunities, including proposals, RFPs, due diligence, and tech assessments.
• Partner with BD, Commercial, PD, Manufacturing, Quality, Regulatory, Finance for proposals.
• Lead risk assessments and process readiness to enable informed business decisions.
• Represent MSAT in client meetings, governance, and strategic engagements.
• Mentor and develop MSAT leaders and teams for technical excellence.
• Drive technology transfer and process validation activities across sites.
• Develop CMC strategies, validation, comparability, and lifecycle management plans.
• Ensure data-driven manufacturing capabilities through analytics and digital tools.

Skills

MSAT leadership

GMP knowledge

Tech transfer

CPV/PPQ knowledge

Risk management

Data analytics

Cross-functional leadership

Education

Master’s or PhD in Engineering/Biotech/Life Sciences

Job description

Minaris Regenerative Medicine Co., Ltd. is seeking a senior MSAT leader to oversee clinical and commercial manufacturing support, technology transfer, and lifecycle management across the Minaris network.

The role requires extensive experience in cell and gene therapy manufacturing, validated leadership, and a strategic focus on risk-based decision making, process optimization, and client delivery. This position may offer remote work options and frequent cross-site collaboration.