Sr. Manager, LVV Manufacturing

The posting, as Genetix Biotherapeutics wrote it

About Genetix Biotherapeutics

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 regulat

[…]
ty 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.