MANUFACTURING SITE GENERAL MANAGER

Bio Usawa; Montreal (administrative region); On-site; CAD 180,000 - 280,000; Full time

Job summary

Bio Usawa in Montreal is seeking a General Manager to lead the biosimilar manufacturing unit, ensuring on-time, on-budget construction and operation. The GM will build the site management team and foster a culture of performance and fulfillment.

You will own quality and regulatory compliance, report to the CEO, manage relationships with government and neighbors, and maintain strong financial performance while aligning operations with corporate goals.

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.

Responsibilities

• Lead on-time, in-budget construction and operation of the biosimilar manufacturing unit.
• Build the site management team and establish a culture of performance and fulfillment.
• Oversee quality and regulatory compliance with direct reporting to Quality and Regulatory Affairs.
• Serve as the external face of manufacturing to the government and community.
• Maintain positive financial performance and coordinate with corporate leadership.

Skills

Leadership

Regulatory compliance experience

Cross-functional team leadership

Education

Advanced degree in Engineering or Life Sciences

Job description

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.