Senior Director Manufacturing

About the Company

A rapidly advancing global Contract Development and Manufacturing Organization (CDMO) renowned for delivering top-tier biologics, sterile injectables, and intricate small molecule products is significantly expanding its commercial manufacturing capabilities in North America. This growth is underscored by new strategic collaborations and a robust investment in U.S. operations to establish an elite manufacturing leadership team.

Role Overview

The Senior Director of Manufacturing will play a pivotal role in defining the trajectory of the U.S. manufacturing network. They will lead operational excellence initiatives during a phase of swift scale-up and growth.

Responsibilities

• Strategically lead and manage multiple U.S.-based manufacturing facilities, overseeing commercial-scale production of biologics drug substances, drug products, and sterile fill-finish operations.
• Oversee site readiness efforts, technology transfers, validation processes, and commercial launches for new projects.
• Recruit, mentor, and develop high-achieving manufacturing teams that include Directors, Managers, and specialists across Upstream, Downstream, Fill-Finish, and Technical Operations.
• Drive key operational performance indicators such as yields, throughput, cost efficiency, and flawless execution.
• Collaborate closely with Quality Assurance, Process Sciences, Engineering, and Supply Chain departments to ensure smooth scale-up and adherence to regulatory standards.
• Promote continuous improvement, spearhead digital manufacturing initiatives, and uphold exemplary safety and quality cultures.
• Be prepared to travel domestically up to 20-30% to various U.S. manufacturing sites.

Requirements

• Over 12 years of progressive leadership experience in pharmaceutical or biologics manufacturing, with a minimum of 5 years in Director-level or higher roles.
• Extensive knowledge and hands-on experience in commercial manufacturing of biologics such as monoclonal antibodies, recombinant proteins, or viral vectors and/or sterile injectable products.
• Demonstrated success managing multiple sites or overseeing large-scale facility expansions alongside commercial product launches.
• Proven ability to build and lead dynamic, high-performance technical teams in rapidly growing environments.
• In-depth understanding of cGMP, FDA and EMA regulations, and validation standards.
• Bachelor's degree in Engineering, Life Sciences, or a closely related discipline required; advanced qualifications such as MS, MBA, or PhD are highly desirable.
• Willingness to undertake domestic business travel as needed.

Compensation and Benefits

• Competitive base salary supplemented by substantial performance bonuses and equity participation opportunities.
• Chance to influence growth at a key stage for a leading CDMO undergoing significant expansion.
• Remote work structure within the U.S. offering direct visibility to senior leadership and tangible impact on corporate success.
• Strong organizational investment in personnel development, innovative technologies, and cutting-edge manufacturing facilities.

Additional Information

This position represents an outstanding opportunity for a visionary manufacturing executive who excels in scaling operations within the biologics and sterile pharmaceutical sector.