Director/Senior Director, MSAT

Overview

The Director / Senior Director of Manufacturing Science and Technology (MSAT) provides leadership and technical governance across all manufacturing and validation activities executed within a global external network of CDMOs/CMOs. Operating within a virtual pharmaceutical model, this role is accountable for the lifecycle management of manufacturing processes, validation strategy, technology transfers, and continuous process verification to ensure robust, compliant, and efficient commercial supply.

This position establishes and drives enterprise MSAT strategy, ensuring alignment with Quality, Regulatory, and Supply Chain objectives while enabling scalable and inspection-ready operations across drug substance and drug product (sterile and oral solid dosage forms). The role serves as a key interface with executive leadership and external partners to ensure performance, compliance, and innovation across the manufacturing network.

Essential Duties and Responsibilities

• Lead and direct the Manufacturing Science and Technology (MSAT) function across external manufacturing partners to support clinical and commercial product supply.
• Develop, implement, and maintain MSAT strategies, standards, and governance processes that support lifecycle management, validation, and manufacturing performance.
• Provide technical oversight for manufacturing processes, validation programs, process monitoring, and continuous improvement activities across CDMO/CMO partners.
• Serve as the primary technical leader for external manufacturing operations, including technology transfers, validation readiness, and commercial launch support.
• Oversee the development, review, and approval of validation master plans, process control strategies, and lifecycle documentation.
• Ensure manufacturing and validation activities are executed in compliance with applicable global regulatory requirements, cGMP standards, and data integrity expectations.
• Lead technical governance and business review processes with external manufacturing partners to monitor performance, resolve escalations, and drive operational excellence.
• Direct process validation activities across all lifecycle stages, including process design, process performance qualification, and continued process verification.
• Support regulatory inspections, audits, investigations, deviations, CAPAs, and regulatory submissions by providing technical expertise and oversight.
• Lead and coordinate cross-functional technology transfer initiatives to ensure successful process transfer, comparability, and manufacturing readiness.
• Partner closely with Quality, Regulatory, Supply Chain, R&D, Commercial, and external stakeholders to align priorities and execute strategic objectives.
• Build, lead, and mentor team members, where applicable, while fostering technical capability, accountability, and cross-functional collaboration.

Requirements

Education and Experience

• Advanced degree (MS/Ph.D.) in chemical engineering, chemistry, pharmaceutical sciences, or related field
• 12+ years of experience in MSAT, process validation, and technical operations within the pharmaceutical or biotechnology industry.
• Experience overseeing CDMOs/CMOs within an external or virtual manufacturing environment.
• Demonstrated leadership experience in strategy development, cross-functional execution, and team management.
• Expertise in process validation, lifecycle management, and technology transfer.
• Experience in sterile, oral solid dosage, biologics, peptides, or high-potency manufacturing environments preferred.

Knowledge and Skills

• Advanced knowledge of global regulatory standards (ICH, FDA, EU) and expertise in process validation, QbD, CPV, and statistical analysis.
• Proven ability to lead complex, cross-functional and global initiatives within a regulated manufacturing environment.
• Strong communication, negotiation, and stakeholder management skills, with demonstrated strategic thinking and business acumen.
• Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion
• Ability to multi-task, professional demeanor, strong attention to detail
• Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
• Must be dependable; someone willing to go the extra-mile to get things done
• Team player with excellent verbal and written communication skills.