Sr. Director, Manufacturing and MST (4437)

<div class="content-intro"><div> <div data-tid="messageBodyContainer"> <div data-tid="messageBodyContent"> <div> <div> <div> </div> </div> </div> </div> </div> </div> <p><strong>About Genetix Biotherapeutics</strong></p> <p>At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:</p> <p>Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.</p> <p> </p></div><p><strong>SUMMARY</strong></p> <p>The Senior Director of Manufacturing & MS&T (Manufacturing Science & Technology) is a strategic and operational leader responsible for overseeing drug product commercial manufacturing operations, technology transfer, and process development support for the company’s gene therapy product portfolio. This role ensures that manufacturing processes are robust, compliant, scalable, and continuously improved to meet commercial demand and regulatory expectations. The Senior Director will partner cross-functionally across Technical Operations and Qulaity to drive high-quality execution across internal development and external manufacturing networks. <strong>This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.</strong></p> <p><strong>RESPONSIBILITIES</strong></p> <p><strong>Manufacturing Leadership</strong></p> <ul> <li>Provide strategic oversight and day-to-day management of GMP manufacturing for gene therapy products across internal development labs and CDMOs.</li> <li>Ensure operations meet safety, quality, cost, and delivery targets while maintaining a culture of compliance and operational excellence.</li> <li>Develop and execute manufacturing readiness strategies commercial production, including staffing, capacity planning, and resource management.</li> <li>Oversee a team that leads investigations, root cause analyses, and CAPA implementation for manufacturing deviations.</li> <li>Oversee Person-in-Plant leadership to ensure proper governance and oversight of CDMO manufacturing</li> </ul> <p><strong>MS&T Leadership</strong></p> <ul> <li>Serve as the technical owner of commercial and late-stage processes, providing subject-matter leadership for drug product manufacturing</li> <li>Oversee technology transfer activities from Process Development to GMP manufacturing, ensuring seamless scaling and process robustness.</li> <li>Oversee process validation strategy, continued process verification (CPV), and lifecycle management.</li> <li>Drive process improvements, new technologies, and comparability studies to enhance consistency, yield, and cost efficiency</li> </ul> <p><strong>Cross-Functional Collaboration</strong></p> <ul> <li>Partner closely with Quality to ensure alignment on compliance, product release timelines, and regulatory inspections.</li> <li>Collaborate with Regulatory Affairs to prepare CMC sections of regulatory submissions (IND, IMPD, BLA/MAA) and respond to health authority questions.</li> <li>Engage with Supply Chain/Logistics on raw material strategy, vendor qualification, and secondary material planning</li> <li>Provide executive-level communication and program updates to senior leadership and governance committees</li> </ul> <p><strong>Leadership & Collaboration</strong></p> <ul> <li>Act as a key member of the CMC Drug Product Team, contributing to the overall CMC and manufacturing strategy</li> <li>Foster a high-performance culture, setting clear expectations, developing talent, and enabling team growth</li> <li>Establish a strong culture of accountability, continuous improvement, and technical rigor</li> </ul> <p><strong>QUALIFICATIONS </strong></p> <p><strong>Education and Experience</strong></p> <ul> <li>Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree (MBA or MS) preferred</li> <li>15+ years of experience in manufacturing, MS&T or CMC roles in the biopharma industry, with at least 7 years in a senior leadership role</li> <li>Deep experience managing contract manufacturing and external supply networks, ideally in cell and gene therapy or other complex modalities</li> <li>Strong understanding of GMP compliance, quality systems, and regulatory expectations for advanced therapies</li> <li>Strategic thinker with strong financial acumen and a hands-on, results-driven leadership style</li> <li>Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization</li> </ul> <p><strong>Skills and Competencies</strong></p> <ul> <li>Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization</li> <li>Deep knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)</li> <li>Exceptional leadership, communication, and cross-functional collaboration skills</li> </ul> <p><strong>Key Attributes</strong></p> <ul> <li>Strong demonstrated leadership across multiple functions within Technical Operations</li> <li>Experience with closed, automated, or semi-automated cell therapy manufacturing platforms</li> <li>Strategic thinker with hands-on operational expertise in manufacturing of cell & gene therapies</li> </ul> <p> </p><div class="content-conclusion"><p><strong>Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.</strong></p></div>