Sr. Manager, LVV Manufacturing

SUMMARY

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.

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 (<10% travel).

RESPONSIBILITIES

Manufacturing Operations

• Provide operational oversight of GMP commercial LVV drug substance manufacturing at the CDMO, including campaign planning, batch readiness, and on-time execution
• Serve as day-to-day point of contact and site liaison to the CDMO for batch scheduling, execution, and issue resolution
• 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
• 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
• Own CAPAs arising from manufacturing events, ensuring timely implementation and effectiveness checks
• 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
• Review and approve CDMO documentation impacting manufacturing operations, such as SOP revisions, protocols, and reports
• Support inspection readiness and participate in regulatory and customer inspections

Supply & Performance Management

• Partner with Supply Chain to align production schedules, raw material availability, and capacity with commercial demand
• Track and report manufacturing performance metrics (e.g., on-time batch release, right-first-time, deviation rates, yield) and escalate risks to the Director
• Support continued process verification (CPV), data trending, and annual product quality review (PQR) activities for commercial LVV manufacturing, including data review and recommendations
• Identify and implement continuous improvement opportunities that improve yield, reliability, and cost of goods

Cross-Functional Collaboration

• 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
• Provide manufacturing input to regulatory filings, responses, and lifecycle submissions related to LVV manufacturing changes
• Contribute to governance forums and lead or participate in joint CDMO operational and quality review meetings

Leadership & Collaboration

• Lead all LVV and starting material meetings, internally and externally.
• Foster a culture of accountability, continuous improvement, and technical rigor
• Build strong, collaborative working relationships with CDMO counterparts

QUALIFICATIONS

Education and Experience

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred
• 6+ years of experience in biopharma manufacturing, with at least 3 years in a people-leadership or supervisory role
• Strong preference for hands-on experience in GMP viral vector manufacturing (lentiviral vector experience preferred) and/or manufacturing oversight; broader cell and gene therapy experience also valued
• Experience working with or overseeing contract development and manufacturing organizations (CDMOs)
• Demonstrated experience reviewing batch records and managing deviations, CAPAs, and change controls in a GMP environment; commercial manufacturing experience preferred
• Working knowledge of GMP compliance, quality systems, and regulatory expectations for advanced therapies

Skills and Competencies

• Proven ability to lead cross-functional work, manage multiple priorities, and influence without direct authority
• Working knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)
• Strong problem-solving, communication, and collaboration skills

Key Attributes

• Hands-on, results-driven leader with strong technical grounding in LVV manufacturing
• Sound judgment and a bias toward accountability and follow-through