Senior Director, Digital Process Development and MSAT

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

Join FUJIFILM Biotechnologies and help make the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive - what we call Genki.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Key Responsibilities

Strategic Leadership & Governance

Develop and execute acomprehensive IT strategyfor Process Development and MSAT ensuring alignment with overall business objectives and IT digital strategy.
Own the fulllifecycle managementof 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 leveragingIndustry 4.0 AI IoT and automationto drive operational excellence.
Establish strong governance frameworks fordata integrity cybersecurity and regulatory compliance(e.g. FDA GMP GxP 21 CFR Part 11)

Process Development & Data Management

Oversee IT support forProcess 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.
Drivedata analytics and digital innovation initiatives enabling multivariate analysis process modeling and AI/ML applications to improve bioprocess optimization and scale-up.
Ensure secure and compliantdata governancepractices across Process Development and Manufacturing leveraging ISA-S88 and ISA-S95 standards.

IT/OT Convergence & Cybersecurity

DriveIT/OT integrationstrategies 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 maintaincybersecurity best practicesfor operational technology (OT) ensuring compliance with global cybersecurity standards and frameworks (e.g. NIST ISA/IEC 62443).
Collaborate with Manufacturing and Automation teams toenable smart factory capabilities including real-time monitoring digital twins and edge computing.

Operational Excellence & Continuous Improvement

Define and implementKPIs and performance metricsto assess system effectiveness efficiency and reliability.

Partner with cross-functional teams to drivecontinuous 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

Bachelors Degree in Computer Science Engineering or related field
12 years of experiencein IT leadership roles supportingManufacturing Process Development or Engineeringin thebiopharmaceutical 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 ofManufacturing Execution Systems (MES) Engineering Systems (EAM CMMS) Process Development Systems (ELN LIMS PDLM) and IT/OT integration.
Strong understanding ofbiomanufacturing processes GMP compliance and regulatory requirements(21 CFR Part 11 GAMP 5 FDA EMA Data Integrity).
Experience leadingdigital 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 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 individuals leadership directly influences the departments 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 organizations 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

*#LI-Onsite

Working Conditions & Physical Requirements:

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.
Will work in heights greater than 4 feet.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Exec

Position OverviewThe 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 ...