Director, Operations - Drug Product (Biologics)

About the role

The Director of Operations – Drug Product will lead the start‑up and ongoing manufacturing of high‑potent biologic medicines, including antibody‑drug conjugates, at the new Wilmington Biotech facility. This senior position reports to the Site Leadership Team and is responsible for delivering safe, compliant, and reliable commercial supply.

Key responsibilities

• Shape site and organizational strategies, overseeing drug product manufacturing for commercial and new product introductions.
• Lead facility start‑up for high‑potent products, ensuring GMP compliance, inspection readiness, and operational excellence.
• Drive technology transfers, commercial approvals, and Lean‑based process optimization across cross‑functional teams.
• Manage financial forecasts, cost‑improvement initiatives, and sustainability targets while leveraging digital tools for decision‑making.
• Monitor and improve KPIs related to hiring, uptime, training, change control, yield, volume, and production cadence.

Required profile

• Degree in Engineering, Science or related field with 8‑12 years of industry experience (PhD + 8 yrs, Masters + 10 yrs, or Bachelor + 12 yrs).
• 6+ years of demonstrated leadership in sterile drug‑product manufacturing, preferably with high‑potent ADCs.
• Proven experience managing cross‑functional teams in biotech/pharma environments and delivering clinical and commercial products.
• Strong understanding of cGMP requirements and regulatory compliance for high‑potent biologics.

Required skills

• Sterile manufacturing
• cGMP compliance
• ADC (antibody‑drug conjugate) manufacturing
• Lean Manufacturing
• Process Optimization
• Data Analysis
• Decision Making
• Manufacturing Technologies
• Quality Management Systems
• Regulatory Compliance

What we offer

• Salary range $173,200 – $272,600 per year, with annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation, and compassionate leave.
• Opportunities to lead a cutting‑edge biologics facility and drive innovative therapies to patients worldwide.