Job Description

The General Manager (GM) reports to the CEO and is ultimately responsible for on-time, in-budget, construction and operation of the biosimilar manufacturing unit. He or she will create an environment where teamwork, productivity, and compliance are reflected in all operations and activities. The GM will build the site management team and establish a site culture of delivering results and enabling employee fulfillment. The GM is ultimately responsible for quality and regulatory compliance of the site and has direct reporting responsibility for the Quality and Regulatory Affairs functions.

The GM will be the external face of the manufacturing operation to the local community and ensure proactive, positive relations with government and neighbors. The GM will have direct responsibility for financial control of site operations and maintain positive financial performance for the site.

The GM will work directly with the CEO and corporate leadership team to ensure integrated operational and strategic planning as well as achievement of yearly corporate goals.

The Position Will Have The Following Direct Reports To

Head of Manufacturing and Process Development (Drug Substance, Drug Product, and Supply Chain) Head of Quality and Regulatory Affairs (Quality Assurance, Quality Control, and CMC Regulatory Affairs) Head of Engineering and Validation Head of Automation and Information Systems The GM/Site will have a ‘dotted line’ reporting relationship to corporate HR and Finance

Qualifications

Advanced degree in Engineering or Life Sciences. 15+ years experience in Biologics/Biotech manufacturing site leadership. Proven track record of delivering project goals and operational excellence in a regulated environment. Expert knowledge of regional and national laws, customs, business practices and labor relations.