Director, Operations - Drug Product (Biologics)

Merck•Wilmington, DE

2d•$173,200 - $272,600•Onsite

About The Position

The Director, Operations – Drug Product will provide strategic and technical leadership for drug product manufacturing at the Wilmington Biotech facility, a new high-potent facility within the company's biologics manufacturing network. The role is responsible for helping realize the facility's strategic projects and ensuring site objectives are achieved in compliance with company requirements, with a focus on safety and reliable customer supply. As a member of the Site Leadership Team, the Director will shape site and organizational strategies and oversee commercial drug product manufacturing and new product introductions. The role includes supporting facility start-up for high-potent products such as antibody-drug conjugates (ADCs), enabling technology transfers and commercial approvals, and leading and developing the operations team. The Director will promote continuous learning and improvement, address resource needs, champion operational and technical excellence, and apply Lean principles to optimize processes. Responsibilities also include maintaining compliance with the Manufacturing Division Quality Management System and inspection readiness; overseeing financial forecasts, workload, and cost improvements against capital and expense targets; contributing to sustainability and cost-reduction initiatives; using digital tools and emerging manufacturing technologies; and delivering onsite KPIs across areas such as hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, and operational availability.

Requirements

Bachelor’s degree or equivalent in Engineering, Science, Technical, or another relevant field, plus 12 years of industry experience; or a master’s degree plus 10 years; or a PhD plus 8 years.
At least 6 years of demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross-functional teams.
Demonstrated experience in a biotech, vaccines, or pharmaceutical manufacturing site, project, or other relevant role, specifically in drug product sterile manufacturing.
Demonstrated experience manufacturing clinical and commercial products.
Understanding of cGMP requirements for commercial high-potent ADC drug product manufacturing.

Nice To Haves

Leadership experience in sterile manufacturing and operations, preferably with multi-product experience.
Ability to inspire and coach and foster a high-performance organizational culture.
Commitment to continuous learning and cultivating ongoing development within the team.
Innovative thinking, with excellent decision-making and problem-solving skills.
Experience leading highly effective cross-functional teams and interest in shaping the organization's future.
Ability to influence and build relationships across organizational levels and with external partners.

Responsibilities

Contribute to strategic project realization and achievement of the Wilmington Biotech facility's mission and objectives.
Serve as a member of the Site Leadership Team and help shape site and organizational strategies.
Oversee drug product manufacturing for commercial products and new product introductions.
Support the start-up of a facility manufacturing high-potent products, including antibody-drug conjugates (ADCs).
Collaborate with cross-functional teams to streamline technology transfers and commercial approvals.
Lead, nurture, and empower the operations team; support departmental alignment through site and cross-functional structures.
Promote continuous learning and improvement.
Address resource constraints and needs, and champion operational and technical excellence for efficient production.
Implement Lean principles to optimize processes.
Uphold Manufacturing Division Quality Management System requirements, manage relevant quality topics, and maintain inspection readiness.
Oversee departmental financial forecasts and workload, pursue cost improvements, and align with capital and expense targets.
Contribute to sustainability and cost-reduction initiatives.
Leverage digital tools and relevant emerging technologies to improve operational efficiency and decision-making.
Achieve onsite KPIs and monitor and improve performance in hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, and operational availability.