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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 program EG-70 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 or naïve to treatment with Bacillus Calmette-Guérin (BCG). EG-70 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 strategic Executive Director of CMC (Chemistry, Manufacturing, and Controls) Supply Chain to join our dynamic team in the biotechnology and pharmaceutical industry. This pivotal role is responsible for overseeing and enhancing our supply chain operations related to drug substance and drug product manufacturing, ensuring efficient and compliant processes that meet both current and future needs.
Key Responsibilities:
Lead the CMC supply chain strategy across multiple projects, ensuring alignment with corporate goals
Oversee the development and optimization of supply chain processes for the sourcing, manufacturing, and distribution of clinical and commercial products
Manage relationships with key external partners, including contract manufacturing organizations (CMOs), raw material suppliers, and third-party logistics providers
Collaborate closely with internal cross-functional teams, including Regulatory Affairs, Quality Assurance, and Project Management, to ensure seamless integration and compliance of supply chain activities with regulatory standards
Drive continuous improvement initiatives, leveraging technology and innovative practices to enhance supply chain efficiency and robustness
Develop and manage budgets, forecasts, and resource allocation to support supply chain activities
Provide strategic leadership and guidance to the supply chain team, fostering a culture of high performance and continuous development
Ensure robust risk management practices are in place to mitigate potential supply chain disruptions
Prepare and present supply chain reports and metrics to senior management, providing insights and strategic recommendations
Qualifications:
Bachelor’s degree in Supply Chain Management, Engineering, Life Sciences, or related field; an advanced degree (Masters) is preferred
Minimum of 15 years of experience in supply chain management within the biotechnology or pharmaceutical industry, with at least 8 years in a senior leadership role
Extensive knowledge of CMC regulatory requirements and industry standards
Proven track record of successfully managing complex supply chains and building effective partnerships
Strong strategic thinking, problem-solving, and decision-making skills
Excellent leadership and communication skills, capable of leading and motivating a diverse team
Proficient in supply chain management software and tools
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.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Finance and Consulting
Industries
Financial Services and Hospitals and Health Care
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