Job Description
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: 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 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 environments
- 5+ 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
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
Current Employees apply HERE
Current Contingent Workers apply HERE
US And Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
Requirements
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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. 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.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$169,700.00 - $267,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
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.
Employee Status
Regular
Relocation:
Domestic
VISA Sponsorship
No
Travel Requirements
25%
Flexible Work Arrangements
Not Applicable
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
11/4/2025
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R370394
