Director, Operations - Drug Product (Biologics)

Principle Roles & Responsibilities / Accountabilities

• Drive strategic project realization of the Wilmington Biotech facility, ensuring site mission and objectives are achieved with compliance, safety, and reliable supply.
• Serve as a key member of the Site Leadership Team, shaping site and organizational strategies and overseeing drug product manufacturing for commercial and new product introductions.
• Support facility start-up to manufacture high-potent products such as antibody drug conjugates (ADCs).
• Collaborate with cross-functional teams to streamline technology transfers and commercial approvals while nurturing and empowering the operations team.
• Foster a culture of continuous learning and improvement, leading or supporting site functional and cross-functional structures for departmental alignment.
• Champion operational and technical excellence for efficient production and implement Lean principles for process optimization.
• Uphold Manufacturing Division Quality Management System (QMS) requirements, manage quality topics, and ensure permanent inspection readiness.
• Oversee financial forecasts and workload for departmental cost improvements, aligning with capital and expense targets and contributing to sustainability and cost reduction initiatives.
• Leverage digital tools for operational efficiency and informed decision-making.
• Achieve onsite Key Performance Indicators (KPIs) related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, operational availability, and more.

Qualification And Experience Required

• 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-functional 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.

Preferred Experience and Skills

• Sterile manufacturing leadership & operations, with preferred multi-product experience.
• A leader who inspires, coaches, and fosters a high-performance organizational culture.
• A continuous learner who cultivates a culture of ongoing development within the team.
• An innovative thinker with excellent decision-making and problem-solving skills.
• Experienced in leading highly effective cross-functional teams with a passion for shaping the future of the organization.
• Capable of influencing and building relationships across organizational layers, as well as externally with partners.