Director, Digital Process Control Solutions

Job Description

General Summary:

Vertex is a global biotechnology company that invests in scientific innovation. The Digital, Technology and Engineering (DTE) team powering Research Technology & Biopharmaceutical Manufacturing have a core mission to improve the lives of patients through digital, data, and technology innovation.

Vertex is accelerating our capabilities, technology and data to augment our manufacturing and supply mission and enable Vertex to grow in scale; ensuring we remain on the forefront of science, medicine and technology.

We are seeking a dynamic and experienced Director, Digital Process Control Solutions to join our team and drive our digital evolution initiatives.

The Director, Digital Process Control Solutions is a pivotal role that will lead the development, implementation, and optimization of data consumption solutions that enable modelling, prediction and digital process control systems, ensuring alignment with Vertex's strategic goals and enhancing product development and manufacturing efficiency and quality. This position requires a visionary leader who can leverage fast paced technology innovation to support Vertex's commitment to innovation across a broad multi-modality medicine portfolio currently including small molecule, cell therapy and gene therapies, a global CMC scientific team and a broad internal and external manufacturing network.

Key Duties and Responsibilities:

• Develop and execute the data and technology strategy for digital manufacturing process control, ensuring alignment with business, regulatory, and operational objectives.
• Develop and align the strategic vision for digital manufacturing process control, aligning with the overall goals the broader goals of the Data, Technology, and Engineering group.
• Collaborate with cross-functional teams to ensure the digital manufacturing process control data and technology strategy supports broader organizational objectives and regulatory requirements.

• Oversee the implementation and management of data and technology solutions that enable digital process control in a focused internal and highly externalized manufacturing environment including digital twins, digital control and simulation services to real-time monitor and control the most effective manufacturing of innovative medicines.
• Deliver a data first strategy with a focus on capturing and flowing insights in process control to optimize future medicines earlier in CMC stages of development, including prediction and digital design of route optimization, form and the design of control strategies and critical process parameters.
• Collaborate with IT and OT teams to integrate control engineering technologies into manufacturing operations.
• Collaborate with IT, data science and scientific teams to deliver upstream solutions that predict first.
• Ensure data and technology solutions are developed on time, within budget, and to the required quality standards.
• Ensure relevant adoption of cloud-based solutions, IoT-enabled manufacturing, and automation technologies improve efficiency, scalability, and cost-effectiveness.
• Ensure compliance with regulatory requirements, including GAMP, GXP, by implementing secure, validated digital systems.
• Monitor and manage performance metrics to track the performance and effectiveness of digital process control systems.

Leadership

• Lead a high-performing, diverse team of professionals, fostering a culture of innovation, collaboration, and accountability.
• Create a culture of inclusion, diversity, and equity where everyone can do their best work and feels valued.
• Communicate effectively with senior leadership and stakeholders to align on strategic priorities, project progress, and the impact of data initiatives.
• Represent the RDMS in cross-functional meetings and initiatives, advocating for data-driven approaches and ensuring alignment with broader organizational goals.
• Align automation portfolio & vision to the business strategy (Governance & Roadmap). Partner with business stakeholders across the enterprise in order to manage and prioritize demand.
• Continually build the future digital automation roadmap to have an ongoing, significant impact towards meeting strategic business goals
• Present ideas and forward-looking plans to, and engage directly with, cross-functional senior leaders on regular basis
• Deploy a multi-disciplinary approach to solving business challenges and unlocking new streams of business value through digital automation projects
• Lead full project lifecycle from intake through deployment, as well as communication, change management and team mobilization/ onboarding
• Establish, track and report on project/program value drivers and financial impact
• Proactively offer innovative technologies, solution ideas, and potential business process improvements in pursuit of driving efficiencies and meeting business needs
• Enhance and improve internal processes and procedures related to demand management, resource management, project delivery, platform releases and ongoing operational support
• Work closely with DTE Compliance, Internal Audit and Quality Assurance groups as needed to ensure compliance with Sarbanes-Oxley (SOX) and GxP regulations, as well as our DTE system lifecycle and change management requirements
• Develop budget for a program or department
• Attract, develop, and retain talent
• As a people manager within the organization, has financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills

• Deep understanding and experience of designing and implementing data and technology solutions in both CMC laboratory and clinical and commercial manufacturing environments.
• Proficiency in data management and automation principles and methodologies.
• Proficiency in rapidly adopting and implementing emerging technology (e.g. AI/ML, agentic).
• Strong analytical and problem-solving skills, with the ability to use data to inform decisions.
• Strong leadership and team management skills, with the ability to inspire and motivate a diverse team.
• Excellent written and verbal communication skills, with the ability to present complex technical concepts to a variety of audiences.
• Able to translate broad business strategies and functional priorities into effective operational goals and objectives; able to actively participate in strategic planning for the function
• Results oriented leader with a proven track record of on-time project delivery for large, cross-functional and complex projects with global stakeholders
• Exceptional written and verbal communication skills and ability to present in a clear and concise manner to all audiences
• Exceptional analytical, quantitative, problem-solving, and prioritization skills, including the development of business cases/ value propositions
• Substantial program/ project management, demand management, resource management and system life cycle expertise
• Superior people management skills and proven success in building high-performing teams
• Strong experience with running IT managed services or outsourced/ offshore teams
• Expertise in Agile methodology and working in Agile environments
• Strong understanding of key concepts related to Software Development Life Cycle, Information Security, and Digital Transformation

Education and Experience

• Bachelor's degree in Engineering, Science Computer Science, or a related field; advanced degree (Master's or Ph.D.) preferred.
• Minimum of 10 years of experience in manufacturing or supply chain management within the biotechnology or pharmaceutical industry.
• Proven track record of implementing and optimizing digital process control systems, digital manufacturing and CMC solutions.
• Extensive experience with regulatory requirements and industry standards, including GMP.
• Experience with the development and manufacturing processes of small molecule, cell therapy, gene therapy and other modalities.

Co-Location Requirement

• This is a hybrid role based in Boston, Massachusetts. The Flex @ Vertex Policy requires 3 days a week, of your choice, on-site.

Other Requirements

• Willingness to travel as needed (up to 30%) to support business objectives.
• Experience with enabling advanced technologies, such as AI and machine learning, and delivery of data engineering strategies is highly desirable.
• Advanced certifications in product, agile, software engineering, cloud technologies, or leadership preferred.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com