Dir., Technology Partnership

Director Of Digital Manufacturing Operations

Do you aspire to secure a critical role in the supply of innovative biologics medicines? Are you excited to lead dynamic teams in a state-of-the-art facility that brings transformative treatments to patients globally? We invite you to become a part of our journey as the Director of Digital Manufacturing Operations (DMO) for the Wilmington Biotech Site. This role offers you the chance to contribute to the site's development and to bring technical leadership for successful GMP manufacturing in launch and supply of new products.

The Digital Manufacturing Operations (DMO) lead creates, builds and grows the team who is responsible for delivering Digital Systems, Automation & IT Services and Technology. The DMO Lead ensures all project, and commercial activities are supported and delivered on schedule. This role partners collaboratively with business and IT leaders throughout our company Manufacturing Division.

What you will do :

Bring energy, knowledge, innovation and leadership to drive progress in the following areas :

• Build and lead the site DMO organization, including the following 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, execution of development and PPQ batches, change control management and implementation, closure of significant technical investigations, process improvement opportunity identification through implementation, regulatory license section authoring through response-to-questions, health authority inspection SME support, and more.
• Provide leadership for execution excellence in new product introduction, and capital project design and execution.
• Resolve operational challenges and identify risks in a timely fashion to the relevant on-site and above-site stakeholders. Ensure project milestones are achieved through planning and execution of integrated overall program schedule.
• Develop and Support targets for continuous improvements in yield, cycle time, system uptime.
• Oversee deployment and use of various systems at our company to achieve a tech-enabled site : MES, Delta V, RTMS, PI and others. Leverage these systems to deliver business value through predictive / proactive issue resolution, rapid investigation closure, improved yield / throughput and more.
• Serve on the Site Leadership Team to develop and deliver against organizational priorities.
• Represent site on relevant global technical teams; identify, capture and cascade best and next practices into and out of site. Lead and support various site and global initiatives.
• Stay current with industry technology trends and introduce best practices to our Companys Digital Strategy.
• Assume accountability for site DMO positions on various Site Councils and Governance, e.g., Quality Council, EHS Council, Risk / Opportunities, Quality Risk Management.
• Lead and / or support various site functional and cross functional tier structures.
• Manage financial forecasts and workload to achieve departmental headcount and budget targets.
• Manage, coach, and mentor the DMO team. Build diverse talent with the capabilities necessary to succeed in commercial manufacture. Inspire, reward and develop individuals, helping them to reach their potential.

What skills you will need : To excel in this role, you will more than likely have :

Technical :

Preferred :

Required 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, Plan of Action and Milestones (POA&M), Process Improvement Projects, Product Risk Management, Program Management, Regulatory Requirements, Stakeholder Relationship Management, Strategic Planning, Technology Trends, Workforce Planning

Preferred Skills :