Senior Director, Process Development and MSAT

Position Overview

The Senior Director, Digital Process Development and MSAT will lead the strategic direction, full lifecycle management, and continuous improvement of all IT systems and digital capabilities that support Process Development and MSAT. This role is responsible for ensuring seamless IT/OT integration, driving digital transformation initiatives, and optimizing technology solutions to enhance operational efficiency, compliance, and innovation in a regulated biomanufacturing environment. 

 

This individual will have 5-7 direct reports and up to 30 indirect reports, whilst working closely with Process Development, MSAT, Quality, IT, and Automation teams to ensure alignment between business needs and technology investments while supporting future-state digital manufacturing initiatives, including advanced analytics, automation, and AI-driven process optimization.

Job Description

Key Responsibilities

Strategic Leadership & Governance

• Develop and execute a comprehensive IT strategy for Process Development and MSAT, ensuring alignment with overall business objectives and IT digital strategy. 
• Own the full lifecycle management of systems supporting Electronic Lab Notebook (ELN), Process Development Lifecycle Management (PDLM), laboratory instrument systems, data integration, and IT/OT Convergence. 
• Lead digital transformation initiatives in Process Development and MSAT, leveraging Industry 4.0, AI, IoT, and automation to drive operational excellence. 
• Establish strong governance frameworks for data integrity, cybersecurity, and regulatory compliance (e.g., FDA, GMP, GxP, 21 CFR Part 11)

Process Development & Data Management 

• Oversee IT support for Process Development and Tech Transfer, ensuring alignment of Electronic Lab Notebooks (ELN), Process Development Lifecycle Management (PDLM), LIMS, and other R&D systems with Process Development and MSAT IT architecture. 
• Drive data analytics and digital innovation initiatives, enabling multivariate analysis, process modeling, and AI/ML applications to improve bioprocess optimization and scale-up. 
• Ensure secure and compliant data governance practices across Process Development and Manufacturing, leveraging ISA-S88 and ISA-S95 standards.

IT/OT Convergence & Cybersecurity 

• Drive IT/OT integration strategies, ensuring secure, scalable, and interoperable architectures between lab systems (eLN, instruments, PLCs, automation systems, PDLM), enterprise, and manufacturing IT solutions. 
• Collaborate with CISO organization to establish and maintain cybersecurity best practices for operational technology (OT), ensuring compliance with global cybersecurity standards and frameworks (e.g., NIST, ISA/IEC 62443). 
• Collaborate with Manufacturing and Automation teams to enable smart factory capabilities, including real-time monitoring, digital twins, and edge computing.

Operational Excellence & Continuous Improvement 

 

• Define and implement KPIs and performance metrics to assess system effectiveness, efficiency, and reliability. 

• Partner with cross-functional teams to drive continuous improvement initiatives, reducing costs and increasing agility in manufacturing operations. 

• Identify and evaluate emerging technologies (e.g. AI/ML, IIoT, blockchain, AR/VR) for potential adoption in manufacturing and process development

 

Education & Experience

• Bachelor’s Degree in Computer Science, Engineering or related field 
• 12+ years of experience in IT leadership roles supporting Manufacturing, Process Development, or Engineering in the biopharmaceutical or life sciences industry. 
• Experience applying ISA-S88 and ISA-S95 process and data standards required.
• 10+ years experience managing, leading, and developing people.
• Deep knowledge of Manufacturing Execution Systems (MES), Engineering Systems (EAM, CMMS), Process Development Systems (ELN, LIMS, PDLM), and IT/OT integration. 
• Strong understanding of biomanufacturing processes, GMP compliance, and regulatory requirements (21 CFR Part 11, GAMP 5, FDA, EMA, Data Integrity). 
• Experience leading digital transformation and smart manufacturing initiatives (Industry 4.0, AI/ML, IIoT, advanced analytics). 

Scope & Impact

• The Senior Director, Digital Process Development and MSAT, holds a broad scope within the IT organization, reporting directly to VP of Digital Manufacturing & Process Development. They are responsible for managing and directing the full ownership and lifecycle management of all technology and process systems supporting process development and MSAT. This includes MSAT, Process Developme