Director, Operations - Drug Product (Biologics)
MSD
Summary
The Director, Operations – Drug Product plays a critical part in strategic project realization of the Wilmington Biotech facility, a new hi-potent facility in our company's Biologic manufacturing network, ensuring that site’s mission and objectives are effectively achieved, consistent with our company's requirements to ensure compliance, safety and reliable supply to our customers.
Job description
As a key member of the Site Leadership Team, you'll have the opportunity to shape site and organizational strategies, overseeing drug product manufacturing for commercial and new product introductions. Be part of facility start-up to manufacture high-potent products, eg antibody drug conjugates (ADCs)
You will work collaboratively with cross-functional teams to streamline technology transfers and commercial approvals, meanwhile nurturing and empowering your operations team. You'll get to foster a culture of continuous learning and improvement, leading or supporting various site functional and cross-functional structures for departmental alignment.
Tackling resource constraints and needs, you will champion operational and technical excellence for efficient production and implement Lean principles for process optimization. Upholding our Manufacturing Division Quality Management System (QMS) requirements, you will manage relevant quality topics, and ensure permanent inspection readiness.
You will oversee financial forecasts and workload for departmental cost improvements, aligning with capital and expense targets while contributing to sustainability and cost reduction initiatives. You will have the chance to leverage digital tools for operational efficiency and informed decision-making, keeping pace with emerging digital technologies relevant to manufacturing processes.
You will be accountable for achieving onsite Key Performance Indicators (KPIs), monitoring and striving to improve performance metrics related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, operational availability, and more.
Requirements
- A degree or equivalent in Engineering, Science, Technical, or other relevant fields: Bachelor’s degree + 12 years industry experience Or Masters + 10 years Or PhD + 8 years
- 6 or more years demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross function teams
- Demonstrated experience in a biotech/vaccines/pharma manufacturing site, project, or other relevant roles, specifically drug product sterile manufacturing
- Demonstrated experience in manufacturing clinical and commercial products
- Understanding of cGMP requirements for commercial high-potent ADC manufacturing of drug product
- Adaptability
- Business Agility
- Continuous Development
- Cross-Functional Project Management
- Customer Delivery
- Data Analysis
- Decision Making
- Lean Manufacturing
- Manufacturing
- Manufacturing Quality Control
- Manufacturing Technologies
- Operations Management
- Organizational Leadership
- People Leadership
- Performance Metrics
- Process Improvements
- Process Optimization
- Product Compliance
- Production Scheduling
- Quality Compliance
- Quality Control Management
- Quality Control Systems
- Quality Management
- Regulatory Compliance
Benefits
- Medical, Dental & Vision
- Retirement benefits
- 401(k)
- Paid holidays
- Vacation
- Compassionate leave
- Sick days
- Annual bonus
- Long-term incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.