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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.

Senior Director Manufacturing