Director, Digital Tech Transfer & Knowledge Management

The Director, Digital Tech Transfer & Knowledge Management, is a critical leadership role responsible for shaping the future of our manufacturing capabilities. This individual will define the strategy, develop the roadmap, and drive the execution of our digital tech transfer and Process Knowledge Management (PKM) initiatives. The role involves leading a multi-disciplinary team to build and enhance systems that streamline the transfer of process knowledge into manufacturing execution. This leader will be a key driver in our strategic programs to create fully integrated and data-driven manufacturing operations, ensuring that critical process information is captured, accessible, and utilized to its full potential throughout the tech transfer lifecycle., * Define and champion the product vision and strategic roadmap for Digital Tech Transfer and Process Knowledge Management (PKM), ensuring alignment with overarching business goals.

• Lead and mentor a high-performing team of product analysts, technology and process specialists, fostering a culture of innovation and execution excellence.
• Oversee the entire lifecycle of digital manufacturing products that support tech transfer, from initial concept and requirement gathering to deployment and continuous improvement.
• Serve as the primary liaison between Science & Technology (S&T), Research, Commercialization and manufacturing operations, and IT to translate complex business needs into scalable and compliant digital solutions.
• Drive the strategy for integrating disparate data sources (e.g., MES, LIMS, process control systems) to create a cohesive process knowledge ecosystem for seamless technology transfer.
• Champion the principles of data integrity and governance to ensure all process data is reliable, accurate, and inspection ready.
• Manage the product backlog, prioritize features based on business value and strategic importance, and communicate progress to executive stakeholders.
• Ensure all digital solutions adhere to industry regulations, including GxP, and internal quality standards.
• Partner with external contract manufacturing organisations (CMOs) to digitise technology transfer and establish secure, standardised, and compliant ongoing process data exchanges.

Required

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with a minimum of ten (10) years of required industry experience.
• Proven track record of supporting pharmaceutical technology transfer and establishing receiving-site readiness, including process knowledge transfer, capability assessment, data preparedness, and operational handover.
• Demonstrated experience in a product management, program leadership, or strategic role delivering large-scale, data-intensive digital products.
• Strong leadership capabilities with experience managing and developing technical and cross-functional teams.
• Exceptional communication and stakeholder management skills, with the ability to influence and align senior leaders and technical experts.
• Deep knowledge of biopharmaceutical manufacturing processes, technology transfer, and their associated data and control systems (e.g., MES, DeltaV, PKM, Databricks, SCADA, PI).
• Proven ability to connect high-level business objectives to detailed technical execution plans.
• Proven capability in implementing and scaling AI solutions in mission-critical, highly regulated environments, with appropriate governance, reliability, security, and compliance controls.

Preferred

• Direct experience implementing or managing Process Knowledge Management (PKM) systems and digital tech transfer solutions.
• Familiarity with advanced analytics, machine learning, and their applications within a manufacturing environment.
• Experience with Agile development methodologies and a mindset geared towards digital innovation.
• Strong background in process analytics (PPA/PPM) and navigating GMP/GxP compliance requirements for digital systems., Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs

Our company is at the forefront of the biopharmaceutical industry, using digital technology to transform manufacturing. Our strategic team manages process knowledge and data across the product lifecycle-from commercialization and technology transfer through ongoing commercial supply. We deliver integrated digital solutions that make critical process information accurate, accessible, and actionable, enabling smarter, faster, and compliant manufacturing across our global network., Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.