Director, Operations - Drug Product (Biologics)

MSD•Wilmington, DE

7d•$173,200 - $272,600•Onsite

About The Position

The Director, Operations – Drug Product is a member of the Site Leadership Team and plays a key role in realizing strategic projects at the Wilmington Biotech facility, a new high-potent facility in the company’s biologics manufacturing network. The position oversees drug product manufacturing for commercial products and new product introductions, and helps ensure the site achieves its mission and objectives while meeting company requirements for compliance, safety, and reliable customer supply. The Director will help start up the facility for high-potent products, including antibody drug conjugates (ADCs), and work with cross-functional teams on technology transfers and commercial approvals. The role develops and empowers the operations team, promotes continuous learning and improvement, and supports site and cross-functional structures that align departments. It also addresses resource needs, advances operational and technical excellence, applies Lean principles, maintains quality-system compliance and inspection readiness, oversees departmental financial forecasts and workload, and contributes to sustainability and cost-reduction initiatives. The role uses digital tools to support operational efficiency and decision-making and is accountable for onsite KPIs related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, and operational availability, among other measures.

Requirements

A degree or equivalent in Engineering, Science, Technical, or another relevant field, with one of the following: Bachelor’s degree plus 12 years of industry experience, Master’s degree plus 10 years, or 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

Sterile manufacturing leadership and operations experience, preferably in a multi-product environment.
Ability to inspire and coach others and foster a high-performance organizational culture.
Commitment to continuous learning and developing a culture of ongoing team development.
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

Help realize strategic projects for the Wilmington Biotech facility and ensure site objectives are achieved in accordance with requirements for compliance, safety, and reliable customer supply.
Serve as a key member of the Site Leadership Team and contribute to site and organizational strategies.
Oversee drug product manufacturing for commercial products and new product introductions.
Participate in facility start-up for high-potent products, including antibody drug conjugates (ADCs).
Collaborate with cross-functional teams to streamline technology transfers and commercial approvals.
Nurture, empower, coach, and mentor the operations team and support a high-performance culture.
Lead or support site and cross-functional structures that promote departmental alignment, continuous learning, and improvement.
Address resource constraints and needs and champion operational and technical excellence.
Implement Lean principles and process optimization to support efficient production.
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 manufacturing technologies to improve operational efficiency and decision-making.
Achieve onsite KPIs and monitor and improve performance in areas including hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, and operational availability.