Director, LVV Manufacturing and MS&T at Genetix Biotherapeutics

Somerville, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

235000.0

Posted On

13 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing, MS&T, GMP Compliance, Quality Systems, Regulatory Affairs, Process Development, Analytical, Technical Leadership, Cross-Functional Collaboration, Project Management, Continuous Improvement, Risk Mitigation, Capacity Planning, Process Characterization, Validation, Root Cause Analysis

Industry

Biotechnology Research

Description

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. SUMMARY The Director of LVV Manufacturing & MS&T will provide strategic and technical leadership for end-to-end lentiviral vector operations, spanning GMP Manufacturing and Manufacturing Sciences & Technology (MS&T). This role is accountable for ensuring reliable commercial supply, driving process robustness and lifecycle management, and leading cross-functional execution across Manufacturing, Quality, Supply Chain, and Regulatory functions for LVV production. The Director will own tech transfer through commercial manufacturing, continuous improvement, and regulatory support, while serving as the PIP for manufacturing operations for the CDMO network. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office. This role will also require travel to manufacturing sites (10% travel). RESPONSIBILITIES Manufacturing Leadership Provide end-to-end ownership of LVV processes, from tech transfer through commercial manufacturing and lifecycle management Establish and execute manufacturing strategy to support commercial demand, pipeline growth, and long-term scalability Partner with Supply Chain to ensure capacity planning, readiness, and risk mitigation Ensure compliant, reliable GMP manufacturing of LVV drug substance for commercial supply Oversee deviation management, CAPAs, change control, and inspection readiness initiatives MS&T Leadership Lead or support MS&T activities including process characterization, validation, comparability, and continued process verification (CPV) Drive process robustness, yield improvement, and cost-of-goods reduction initiatives Provide technical leadership for process deviations, investigations, and root cause analysis Cross-Functional Collaboration Act as a key technical interface with Quality, Regulatory Affairs, Process Development, Analytical, and External Manufacturing partners Support regulatory filings, responses, and lifecycle submissions related to LVV manufacturing changes Represent LVV manufacturing in governance forums and senior leadership discussions Leadership & Collaboration Lead the LVV manufacturing team contributing to the overall CMC and manufacturing strategy for commercial products Collaborate closely with CDMO as site liaison for all Tech Transfer and Manufacturing activities Establish a strong culture of accountability, continuous improvement, and technical rigor QUALIFICATIONS Education and Experience Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree (MBA or MS) preferred 12+ years of experience in manufacturing, MS&T or CMC roles in the biopharma industry, with at least 5 years in a senior leadership role Deep experience managing contract manufacturing and external supply networks in LVV manufacturing Strong understanding of GMP compliance, quality systems, and regulatory expectations for advanced therapies Strategic thinker with strong financial acumen and a hands-on, results-driven leadership style Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization Skills and Competencies Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization Deep knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA, ICH) Exceptional leadership, communication, and cross-functional collaboration skills Key Attributes Strong demonstrated leadership across multiple functions within Technical Operations Strategic thinker with hands-on operational expertise in LVV manufacturing Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. Pay Transparency $220,000—$235,000 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.

Responsibilities

The Director will provide strategic and technical leadership for end-to-end lentiviral vector operations, ensuring reliable commercial supply and driving process robustness. This role includes overseeing cross-functional execution across Manufacturing, Quality, Supply Chain, and Regulatory functions.