Sr. Manager, LVV Manufacturing

<div class="content-intro"><div> <div data-tid="messageBodyContainer"> <div data-tid="messageBodyContent"> </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></div><p style="text-align: center;"><strong>This is a full-time hybrid position based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered</strong><strong>.</strong></p> <p><strong></strong></p> <div> <p></p> <p><strong>SUMMARY</strong></p> <p>The Senior Manager, Lentiviral Vector (LVV) Manufacturing will provide hands-on operational leadership for GMP lentiviral vector manufacturing, ensuring reliable, compliant, on-time production to support commercial supply. This role is accountable for the day-to-day oversight of commercial LVV manufacturing at our contract development and manufacturing organization (CDMO), including master batch record (MBR) and executed batch record review, deviation and CAPA management, and change control, in close cross-functional partnership with Quality, Supply Chain, MS&T, Process Development, Analytical, and Regulatory functions.</p> <p>The Senior Manager will serve as a key site liaison and person in plant (PIP) for manufacturing activities at the CDMO (as necessary), and will report to the Director, Lentiviral Vector Manufacturing and MS&T. This role will also be responsible for starting materials management. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office. This role will also require occasional travel to manufacturing sites (<u><</u>10% travel).</p> <p><strong>RESPONSIBILITIES</strong></p> <p><strong>Manufacturing Operations</strong></p> <ul> <li>Provide operational oversight of GMP commercial LVV drug substance manufacturing at the CDMO, including campaign planning, batch readiness, and on-time execution</li> <li>Serve as day-to-day point of contact and site liaison to the CDMO for batch scheduling, execution, and issue resolution</li> <li>Review and approve MBRs and MBR revisions, and review executed batch records for accuracy, completeness, and GMP compliance to drive right-first-time execution and timely batch disposition</li> <li>Own deviations and investigations related to commercial LVV manufacturing, including review and approval of CDMO-initiated events, ensuring sound root cause analysis, product impact assessment, and timely closure</li> <li>Own CAPAs arising from manufacturing events, ensuring timely implementation and effectiveness checks</li> <li>Author, review, and approve change controls (CDMO-initiated and Genetix-initiated) affecting commercial LVV manufacturing, assessing process, quality, supply, and regulatory impact and coordinating implementation</li> <li>Review and approve CDMO documentation impacting manufacturing operations, such as SOP revisions, protocols, and reports</li> <li>Support inspection readiness and participate in regulatory and customer inspections</li> </ul> <p><strong>Supply & Performance Management</strong></p> <ul> <li>Partner with Supply Chain to align production schedules, raw material availability, and capacity with commercial demand</li> <li>Track and report manufacturing performance metrics (e.g., on-time batch release, right-first-time, deviation rates, yield) and escalate risks to the Director</li> <li>Support continued process verification (CPV), data trending, and annual product quality review (PQR) activities for commercial LVV manufacturing, including data review and recommendations</li> <li>Identify and implement continuous improvement opportunities that improve yield, reliability, and cost of goods</li> </ul> <p><strong>Cross-Functional Collaboration</strong></p> <ul> <li>Partner with Quality, Regulatory Affairs, MS&T, Process Development, and Analytical teams to support successful process changes, lifecycle activities, and resolution of manufacturing and quality events</li> <li>Provide manufacturing input to regulatory filings, responses, and lifecycle submissions related to LVV manufacturing changes</li> <li>Contribute to governance forums and lead or participate in joint CDMO operational and quality review meetings</li> </ul> <p><strong>Leadership & Collaboration</strong></p> <ul> <li>Lead all LVV and starting material meetings, internally and externally.</li> <li>Foster a culture of accountability, continuous improvement, and technical rigor</li> <li>Build strong, collaborative working relationships with CDMO counterparts</li> </ul> <p><strong>QUALIFICATIONS </strong></p> <p><strong>Education and Experience</strong></p> <ul> <li>Bach