Sr. Manager, LVV Manufacturing

Genetix Biotherapeutics•Somerville, MA

3d•Hybrid

About The Position

The Senior Manager, Lentiviral Vector (LVV) Manufacturing provides hands-on operational leadership for GMP lentiviral vector manufacturing, ensuring reliable, compliant, on-time production to support commercial supply. The role oversees day-to-day commercial LVV manufacturing at a contract development and manufacturing organization (CDMO), including master batch record and executed batch record review, deviation and CAPA management, change control, and starting materials management. The Senior Manager partners closely with Quality, Supply Chain, MS&T, Process Development, Analytical, and Regulatory functions; serves as a key CDMO site liaison and person in plant for manufacturing activities as necessary; and reports to the Director, Lentiviral Vector Manufacturing and MS&T. This is a full-time hybrid position based in the Somerville, Massachusetts (Assembly Row) office, with onsite presence required three days per week. Candidates must reside within commuting distance. Occasional travel to manufacturing sites is required, at less than 10%.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related field.
At least 6 years of experience in biopharma manufacturing.
At least 3 years in a people-leadership or supervisory role.
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.
Working knowledge of GMP compliance, quality systems, and regulatory expectations for advanced therapies.
Ability to lead cross-functional work, manage multiple priorities, and influence without direct authority.
Working knowledge of cGMP, GDP, and regulatory requirements, including FDA, EMA, and ICH.
Strong problem-solving, communication, and collaboration skills.
Hands-on, results-driven leadership, strong technical grounding in LVV manufacturing, sound judgment, accountability, and follow-through.

Nice To Haves

An advanced degree.
Hands-on experience in GMP viral vector manufacturing, with lentiviral vector experience preferred; broader cell and gene therapy experience is also valued.
Commercial manufacturing experience.

Responsibilities

Provide operational oversight of GMP commercial LVV drug substance manufacturing at the CDMO, including campaign planning, batch readiness, and on-time execution.
Serve as the 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.
Own deviations and investigations related to commercial LVV manufacturing, including review and approval of CDMO-initiated events, 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 affecting commercial LVV manufacturing, assessing process, quality, supply, and regulatory impact and coordinating implementation.
Review and approve CDMO documentation affecting manufacturing operations, such as SOP revisions, protocols, and reports.
Support inspection readiness and participate in regulatory and customer inspections.
Partner with Supply Chain to align production schedules, raw material availability, and capacity with commercial demand.
Track and report manufacturing performance metrics, including on-time batch release, right-first-time, deviation rates, and yield, and escalate risks to the Director.
Support continued process verification, data trending, and annual product quality review activities, including data review and recommendations.
Identify and implement continuous improvement opportunities to improve yield, reliability, and cost of goods.
Partner with Quality, Regulatory Affairs, MS&T, Process Development, and Analytical teams to support 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.
Lead all LVV and starting material meetings, internally and externally.
Foster a culture of accountability, continuous improvement, and technical rigor, and build strong collaborative relationships with CDMO counterparts.