Senior Director, Process Development and MSATFUJIFILM • Holly Springs, NC, US
Senior Director, Process Development and MSAT
FUJIFILM • Holly Springs, NC, US
2 days ago
Job type
- Full-time
Job descriptionOversee 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. 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. 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 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). 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 Development, and IT / OT Convergence. The role oversees multiple cross-functional teams, coordinating between IT and operational departments to ensure seamless integration of technology systems in manufacturing settings. The individual is pivotal in driving strategic initiatives that enhance digital transformation within manufacturing facilities. The role actively involves designing, implementing, and optimizing workflows within the organization that directly impact development processes, ensuring that systems are aligned with industry best practices and regulatory compliance. The individual is accountable for managing and optimizing the technology budget associated with process development operations, making key financial decisions to ensure efficient allocation of resources and achieving cost-effective technological advancements This role plays a critical role in shaping the success and efficiency of the manufacturing operations within the organization, directly impacts both internal processes and external stakeholder relations through several key areas : Through overseeing the integration of cutting-edge technologies and systems, the Senior Director ensures the company remains at the forefront of biomanufacturing. By improving system reliability and product quality, the role fosters greater trust and satisfaction among external stakeholders, including suppliers, partners, and clients. The individual's leadership directly influences the department's ability to meet its operational and strategic objectives. By driving technology and process innovation, this role enhances operational efficiency, reduces downtime, and ensures the alignment of manufacturing systems with business goals. This, in turn, contributes to the overall profitability and competitiveness of the business unit. This role acts as a key advisor to the CIO and other senior leaders, offering insights and technical expertise that influence high-level decision-making. The Senior Director provides recommendations on strategic technology and process improvements, acting as a liaison between technical teams and executive management to ensure that objectives are met with precision and foresight. The Senior Director, Process Development and MSAT, is entrusted with a high degree of decision-making responsibility, particularly in managing complex challenges inherent to the biomanufacturing process : Must swiftly prioritize issues, balancing immediate operational demands with long-term strategic goals. Quick and decisive leadership is necessary to address system failures, ensure business continuity, and implement enhancements that prevent future issues. This requires the ability to evaluate various courses of action, forecast potential outcomes, and choose solutions that best serve the organization's objectives. The role routinely encounters high-complexity issues, including integrating new technologies with legacy systems, aligning IT and operational technologies, and ensuring adherence to stringent regulatory standards. These situations require deep technical understanding and innovative problem-solving capabilities to devise solutions that mitigate risks without disrupting operations. The role provides significant latitude in decision-making, operating independently within defined organizational strategies to develop and implement process improvements and technological integrations. The Senior Director exercises discretion in allocating resources, selecting technological partners, and setting operational priorities, in alignment with broader company policies and business goals. Will work in environment which may necessitate respiratory protection. May work in Mechanical / Production spaces that may require hearing protection and enrollment in a hearing conservation program. Will work in environment operating a motor vehicle or Powered Industrial Truck. Ability to discern audible cues. Ability to inspect or perform a task with 20 / 20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time, up to 120 minutes Ability to sit for prolonged periods of time, up to 120 minutes Ability to operate machinery and / or power tools. Ability to conduct activities using repetitive motions that include writs, hands and / or fingers Ability to conduct work that includes moving objects up to 50 pounds Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. Will work in warm / cold environments 0-110 F Will work in outdoor elements such as precipitation and wind. Will work in small and / or enclosed spaces.
Senior Director, Digital Process Development And MSAT
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.
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
IT / OT Convergence & Cybersecurity
Operational Excellence & Continuous Improvement
Education & Experience
Scope & Impact
Working Conditions & Physical Requirements :
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Director Development • Holly Springs, NC, US
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