Director, Senior Director Commercial Manufacturing

The Company

enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead product candidate, detalimogene voraplasmid, is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive to BCG. Detalimogene voraplasmid was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com.

Role

We are seeking a highly experienced and visionary Biologics Commercial Manufacturing Leader to join our growing organization in the biotechnology and pharmaceutical industry. This critical leadership position is responsible for overseeing the end-to-end manufacturing of biologics, ensuring high-quality, cost-effective, and scalable operations to meet clinical and commercial demands. The successful candidate will be instrumental in shaping the future of our biologics manufacturing strategy, driving operational excellence and delivering life-changing therapies to patients worldwide.

• Develop and execute a comprehensive biologics manufacturing strategy to support organizational growth and commercial objectives.
• Provide technical and operational leadership to ensure robust manufacturing processes that meet current and future product pipeline requirements.
• Identify and implement innovative technologies to enhance process efficiency, quality, and scalability.
• Align manufacturing strategies with corporate goals, regulatory landscapes, and market trends.

• Oversee the operational planning, production scheduling, and execution of biologics manufacturing, including upstream and downstream processes, as well as fill-finish and packaging operations.
• Manage all aspects of technology transfer, ensuring smooth and efficient transitions from process development to full-scale commercial production.
• Collaborate with internal stakeholders, including Quality Assurance, Regulatory Affairs, Process Development, and Supply Chain, to ensure seamless integration of manufacturing activities.
• Drive adherence to Good Manufacturing Practices (GMP), ensuring compliance with global regulatory standards (e.g., FDA, EMA,ICH).

• Establish and maintain strong relationships with external manufacturing partners, including Contract Manufacturing Organizations (CMOs) and suppliers, ensuring quality, reliability, and cost-effectiveness.
• Negotiate contracts, manage performance, and resolve any operational challenges with external partners.

• Implement and drive continuous improvement initiatives across manufacturing operations, leveraging data-driven insights, Lean principles, and Six Sigma methodologies.
• Lead efforts to enhance process robustness, reduce costs, and minimize production risks.

• Develop, implement, and maintain KPIs to measure and monitor manufacturing performance across key areas, including productivity, yield, cycle times, compliance, cost efficiency, and supply reliability.
• Ensure KPIs are aligned with corporate objectives and provide actionable insights for continuous improvement.
• Regularly review and refine KPI metrics to reflect changes in business needs and operational priorities.
• Utilize KPI data to prepare detailed reports and present operational updates, trends, and strategic recommendations to senior leadership.

• Identify and proactively manage risks associated with biologics manufacturing, including supply chain disruptions, equipment downtime, and regulatory changes.
• Develop and implement contingency plans to ensure uninterrupted product supply.

• Build, lead, and mentor a high-performing manufacturing team, fostering a culture of accountability, innovation, and professional growth.
• Provide coaching, development opportunities, and performance feedback to team members to ensure a motivated and skilled workforce.

• Strong leadership skills, with a proven ability to manage and inspire cross-functional teams in a matrixed environment.
• Exceptional problem-solving, strategic thinking, and decision-making abilities.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external partners.
• Proficiency in manufacturing and quality management systems, as well as relevant software tools.
• Strong financial acumen, including experience with budgeting, forecasting, and resource allocation.

• A minimum of 15 years of experience in biologics manufacturing, with a proven track record in commercial operations.
• At least 8 years of experience in a senior leadership role overseeing large-scale biologics manufacturing operations.
• Demonstrated expertise in upstream (cell culture) and downstream (purification)processes, as well as fill-finish and packaging.
• Comprehensive knowledge of global regulatory requirements, quality systems, and compliance frameworks for biologics.
• Certification in Lean Six Sigma or other process improvement methodologies.
• Experience managing global manufacturing networks, including multi-site operations.
• Familiarity with advanced manufacturing technologies, such as single-use systems, continuous processing, or digital manufacturing tools.
• Prior involvement in commercial launches and lifecycle management of biologics products

enGene USA Inc. is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.  At enGene USA Inc., we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.