Job Description

Position Overview:

The Senior Director, MSAT Biologics provides strategic and technical leadership for all late-stage and commercial manufacturing processes for the company's biologics portfolio executed at CDMOs. This role is responsible for building and leading the MSAT team, ensuring robust and compliant manufacturing processes through effective technology transfer, validation, process monitoring, and lifecycle management. This individual will serve as the primary technical steward for manufacturing processes, ensuring strong collaboration between internal functions and external partners.

Key Responsibilities:

• Develop and implement the overall MSAT strategy supporting the company's portfolio, focusing on technical oversight of CDMO manufacturing operations.
• Build, lead, mentor, and manage the MSAT team, fostering a culture of scientific excellence, collaboration, and accountability.
• Provide senior technical leadership and oversight for technology transfer activities to new or existing CDMOs.
• Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards.
• Establish and oversee robust Continued Process Verification (CPV) programs for commercial products.
• Serve as the primary technical point of contact for CDMOs regarding process performance, troubleshooting, and improvements.
• Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs.
• Drive strategies for process optimization, yield improvement, and manufacturing cost reduction where appropriate.
• Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product lifecycle management
• Lead root cause investigations for manufacturing deviations and implement corrective and preventive actions
• Stay abreast of emerging trends and technologies in biologics manufacturing, recommending and implementing innovations where appropriate
• Ensure compliance with cGMP regulations and other relevant quality standards
• Represent the MSAT function in interactions with regulatory agencies and during audits
• Manage budgets and resources effectively to meet departmental and organizational goals

Qualifications:

• Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field
• Minimum 15 years of experience in biologics manufacturing, with at least 5 years in a senior leadership role
• Deep understanding of upstream and downstream bioprocessing, including cell culture, purification, and formulation
• Proven track record in process development, scale-up, and technology transfer of biologics products
• Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing
• Experience with PAT (Process Analytical Technology) and QbD (Quality by Design) principles
• Excellent leadership and team management skills, with the ability to motivate and develop staff
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making
• Outstanding communication skills, both written and verbal, with the ability to influence at all levels of the organization
• Experience in managing complex projects and driving continuous improvement initiatives

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