Sr. Manager, LVV Manufacturing

Genetix Biotherapeutics; Somerville (MA); Hybrid; USD 155,000 - 165,000; Full time

Benefits offered by this job

Health and disability insurance

Employer‑matched 401(k)

Lifestyle spending account

Flexible time-off + holidays

Tuition reimbursement & loan repayment

Paid parental leave

Paid onsite parking

Commuter subsidy

Job summary

Genetix Biotherapeutics in Somerville, MA is seeking a Senior Manager, Lentiviral Vector Manufacturing to lead GMP LVV production at the CDMO. You will manage MBR/batch review, deviations, CAPAs, change controls, and regulatory coordination.

Responsibilities include site liaison, starting materials management, and cross-functional collaboration with QA, Regulatory, MS&T, and Process Development. Hybrid role, with <10% travel and three on-site days per week.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 6+ years in biopharma manufacturing, with 3+ years in leadership.
• Hands-on GMP viral vector manufacturing experience preferred.
• Experience overseeing CDMOs and batch records in GMP.

Responsibilities

• Provide operational oversight of GMP LVV drug substance manufacturing at the CDMO.
• Review and approve MBRs and batch records for GMP compliance.
• Own deviations, investigations, CAPAs, and change controls.
• Lead LVV and starting material meetings, internally and externally.
• Support inspection readiness and participate in regulatory/customer inspections.

Skills

Cross-functional leadership

GMP experience

Lentiviral vector

CDMO oversight

Deviations & CAPAs

Change control

MBR review

Regulatory collaboration

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Advanced degree preferred

Job description

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:

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.

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.

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 escalation 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
• 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

Additional Information

The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long‑term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job‑related factors permitted by law.

Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer‑matched 401(k) plan, lifestyle spending account, flexible time‑off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay Transparency

$155,000 - $165,000 USD

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.