Sr. Manager, LVV Manufacturing

Genetix Biotherapeutics•Somerville, MA

2d•$155,000 - $165,000•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 (MBR) and executed batch record review, deviation and CAPA management, and change control, in partnership with Quality, Supply Chain, MS&T, Process Development, Analytical, and Regulatory functions. The Senior Manager serves as a key site liaison and person in plant (PIP) for CDMO manufacturing activities as needed and is responsible for starting materials management. The role reports to the Director, Lentiviral Vector Manufacturing and MS&T. It is a full-time hybrid position based in the Somerville, Massachusetts (Assembly Row) office, with onsite presence three days per week. Candidates must live 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, including 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 and strong technical grounding in LVV manufacturing.
Sound judgment and a bias toward accountability and follow-through.
Must reside within a commutable distance of the Somerville, Massachusetts office.
Able to meet the hybrid onsite schedule of three days per week and occasional travel to manufacturing sites of less than 10%.

Nice To Haves

Advanced degree.
Hands-on experience in GMP viral vector manufacturing; lentiviral vector experience is preferred.
Broader cell and gene therapy experience.
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 CDMO point of contact and site liaison 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 CDMO-initiated and Genetix-initiated change controls affecting commercial LVV manufacturing, assessing process, quality, supply, and regulatory impact and coordinating implementation.
Review and approve CDMO documentation affecting manufacturing operations, including 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 performance, deviation rates, and yield, and escalate risks to the Director.
Support continued process verification (CPV), data trending, and annual product quality review (PQR) 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 on 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 accountability, continuous improvement, and technical rigor.
Build strong, collaborative working relationships with CDMO counterparts.
Manage starting materials.