Digital Manufacturing Operations (DMO) Leader
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 :
- 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 Company's 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 :
Required :
Bachelor's degree in computer science, systems analysis or a related technical / engineering study.10+ years prior experience in Enterprise, Business, Information, Systems & Application or Solution Architectures.10+ years of experience in technology-intensive manufacturing operations, or in IT / Automation leadership roles, in complex, matrixed environments5+ years in a management role.5+ years of experience working on-site in a leadership role in a GMP manufacturing environment (direct and indirect reports considered), ideally in the technology enablement of manufacturing.Technical :
Knowledge of Digital & Automation systems that support pharmaceutical manufacture (MES, LIMS etc.), management and data capture systems and other analytics-based systems.Seasoned, action-oriented leader with proven capabilities in site manufacturing, technical operations, validation.Knowledge of and practical experience in applying Six Sigma and Lean methodologies.Knowledge of global health regulatory requirements and requirements that drive IT delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Manufacturing practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems.Preferred :
Strong leadership and interpersonal skills.High personal integrity, credibility, and energy.Enterprise mindset, Innovative thinker, with excellent decision-making and problem-solving skills.Leads with energy and enthusiasm. The DMO Director is a role model for operational excellence and contributes to the organization's overall capability to thrive and grow.Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of our company.Excellent organizational and time management skills.A great communicator, decisive decision maker with a proven ability to deliver excellence.Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.The desire to continuously learn, improve and develop.Experience in the technology enablement of manufacturing.Experience in complex, matrixed environments.Knowledge of regulatory requirements related to computerized systems.Experience in driving technologically driven transformation programs.Understanding of agile delivery models and / or lean-six-sigma approaches.Required Skills :
AccountabilityBenefits ManagementBusiness AnalysisBusiness Process ImprovementsCapital ProjectsComputer ScienceDigital ManufacturingGlobal InitiativesGMP ComplianceGovernance ManagementInformation Systems ManagementLeadershipNew Product Introduction ProcessPharmaceutical SystemsPlan of Action and Milestones (POA&M)Process Improvement ProjectsProduct Risk ManagementProgram ManagementRegulatory RequirementsStakeholder Relationship ManagementStrategic PlanningTechnology TrendsWorkforce PlanningPreferred Skills :
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.