Job Description

Digital Manufacturing Operations (DMO) Leader

Overview

Director level role leading Digital Manufacturing Operations (DMO) for the Wilmington Biotech Site. Responsible for delivering Digital Systems, Automation & IT Services and Technology, supporting project and commercial activities, and partnering with business and IT leaders across the Manufacturing Division.

What you will do

• Build and lead the site DMO organization, including the pillars: IT and Automation, Computer System Validation, Service management, Digitization.
• Ensure right-first-time and on-time-in-full commercial approval and site startup through technology transfer leadership, development and PPQ batches, change control, investigations, process improvement, regulatory responses, health authority inspection support, and related activities.
• Provide leadership for execution excellence in new product introduction and capital project design/execution.
• Resolve operational challenges and risks in a timely fashion; ensure milestones are met via integrated program planning and execution.
• Develop and support targets for continuous improvements in yield, cycle time, and system uptime.
• Oversee deployment and use of MES, DeltaV, RTMS, PI and other systems; leverage for predictive issue resolution, faster investigations, improved yield/throughput, and value delivery.
• Participate in Site Leadership Team and global/functional initiatives; represent site on relevant technical teams and governance bodies.
• Stay current with industry technology trends and introduce best practices to the company Digital Strategy.
• Lead site DMO positions on Site Councils and Governance (Quality, EHS, Risk/Opportunities, Quality Risk Management).
• Lead and/or support cross-functional structures; manage financial forecasts and workload to meet departmental headcount and budget targets.
• Coach and mentor the DMO team; build diverse talent and develop individuals to reach their potential.

What skills you will need

Required

• Bachelors degree in computer science, systems analysis or related technical/engineering field.
• 10+ years in Enterprise, Information, Systems & Application or Solution Architectures.
• 10+ years in technology-intensive manufacturing operations or IT/Automation leadership in complex environments.
• 5+ years in a management role.
• 5+ years on-site in a leadership role in a GMP manufacturing environment (direct or indirect reports), ideally enabling manufacturing technology.

Technical

• Knowledge of Digital & Automation systems that support pharmaceutical manufacture (MES, LIMS, etc.), data capture systems and analytics-based systems.
• Experience as a site manufacturing/technical operations leader; knowledge of Six Sigma and Lean methodologies.
• Regulatory understanding including 21-CFR-Part-11, Annex 11, GLP/GMP, Computer Systems Validation, and related IT regulatory requirements.

Preferred

• Strong leadership, integrity, energy, and interpersonal skills.
• Enterprise mindset with innovative thinking and solid decision-making/problem-solving skills.
• Ability to lead cross-functional teams, build diverse talent, and drive operational excellence.
• Excellent organizational and time management skills; clear communication and accountability for results.
• Experience with technology enablement of manufacturing and working in complex, matrixed environments.
• Knowledge of regulatory requirements related to computerized systems and transformation programs; familiarity with agile or lean-six-sigma approaches.

Required/Preferred Skills

Accountability, Benefits Management, Business Analysis, Business Process Improvements, Capital Projects, Computer Science, Digital Manufacturing, Global Initiatives, GMP Compliance, Governance Management, Information Systems Management, Leadership, New Product Introduction Process, Pharmaceutical Systems, Program Management, Regulatory Requirements, Stakeholder Relationship Management, Strategic Planning, Technology Trends, Workforce Planning

Additional information

US and Puerto Rico residents only; Hybrid work model in the U.S. effective September 5, 2023 (three on-site days per week, Friday remote unless critical tasks require on-site). Salary range: $169,700.00 - $267,200.00. Eligible for annual bonus and long-term incentives where applicable. Benefits include medical/dental/vision, retirement plan (401(k)), holidays, vacation, and sick leave. Application process and deadlines are provided by Merck.

Location

Exton, PA; Newark, DE; Greater Philadelphia area; Malvern, PA; etc.

Posting and compliance notes

Equal Employment Opportunity employer; reasonable accommodations available on request. See EEOC rights and related notices for more information.

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