Director of Manufacturing Science and Technology (MSAT)

Director of Manufacturing Science and Technology (MSAT)

Biopharma Manufacturing Facility

About the Opportunity

Our client, a global leader in the biopharmaceutical industry, is seeking an experienced professional to direct the Manufacturing Science and Technology (MSAT) department at one of their flagship sites. This strategic leadership role is essential for managing innovative therapies, ensuring robust technical processes, and driving operational excellence in manufacturing.

The Director of MSAT will oversee critical areas such as technology transfer, process validation, product lifecycle management, and continuous improvement initiatives, collaborating across multiple teams and functions.

Key Responsibilities:

Strategic Oversight

• Lead a high-performing MSAT team to execute seamless product introductions, technical transfers, and process validation for large molecules and advanced therapies.
• Drive lifecycle management initiatives, aligning operational processes with global strategies to enhance product quality and efficiency.

Process Leadership

• Manage validation activities, including cleaning validation and performance qualification, ensuring compliance with regulatory and quality standards.
• Develop and deploy manufacturing process standards, leveraging cutting-edge technology and data-driven insights.

Cross-functional Collaboration

• Act as the main point of contact between MSAT and departments including Quality, R&D, Manufacturing, and Regulatory, ensuring alignment on project priorities.
• Represent MSAT in regulatory inspections and audits, ensuring adherence to compliance standards and fostering a culture of continuous improvement.

Innovation and Continuous Improvement

• Promote a culture of innovation by identifying and implementing process improvements to optimize manufacturing efficiency and scalability.
• Deploy advanced manufacturing technologies, such as Process Analytical Technology (PAT), to maintain competitive industry positioning.

Leadership and Team Development

• Build and mentor a world-class team of scientists, engineers, and project managers to support MSAT objectives.
• Foster a collaborative and inclusive culture focused on accountability, adaptability, and technical innovation.
• Provide regular coaching, performance evaluations, and development opportunities to ensure the team thrives in a dynamic and fast-paced environment.

Compliance and Quality Excellence

• Uphold the highest standards of quality, safety, and compliance in all MSAT-related activities.
• Ensure manufacturing processes meet or exceed regulatory requirements for biopharmaceutical production, supporting audit readiness at all times.
• Oversee the management and execution of the site’s Validation Master Plan, ensuring consistent delivery of quality products to patients.

Operational Excellence

• Monitor process performance, identify opportunities for cost-saving measures, and implement strategies to enhance productivity.
• Maintain uninterrupted supply of biopharmaceutical products, aligning resources effectively to meet business demands.

Qualifications and Experience

• Bachelor’s or advanced degree in a relevant field such as Biochemistry, Pharmaceutical Sciences, or Engineering.
• A minimum of 10 years of experience in the biopharmaceutical industry, with expertise in large-molecule production, process validation, and MSAT functions.
• Demonstrated ability to lead cross-functional teams, manage complex projects, and deliver measurable results.
• Strong knowledge of regulatory compliance requirements and quality management systems.
• Excellent communication and leadership skills, with the ability to inspire and develop high-performing teams.

For inquiries and applications, contact Harreda Talent Partners at Contact@Harreda.com.

Harreda Talent Partners specializes in executive search for the life sciences industry. We connect exceptional leaders with transformative opportunities to shape the future of healthcare.