Sr. Manager, LVV Manufacturing

The role

The Senior Manager, Lentiviral Vector (LVV) Manufacturing provides operational leadership for GMP lentiviral vector manufacturing. This role oversees commercial LVV manufacturing at a CDMO and manages starting materials.

What you will do

• Provide operational oversight of GMP commercial LVV drug substance manufacturing at the CDMO
• Serve as day-to-day point of contact and site liaison to the CDMO
• Review and approve MBRs and MBR revisions
• Review executed batch records for accuracy, completeness, and GMP compliance
• Own deviations and investigations related to commercial LVV manufacturing
• Own CAPAs arising from manufacturing events
• Author, review, and approve change controls affecting commercial LVV manufacturing
• Review and approve CDMO documentation 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

Required qualifications

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

Nice to have

• advanced degree
• hands-on experience in GMP viral vector manufacturing
• lentiviral vector experience
• broader cell and gene therapy experience
• commercial manufacturing experience

Benefits

• comprehensive health, life and disability insurance
• employer-matched 401(k) plan
• lifestyle spending account
• flexible time-off
• paid holidays
• winter holiday period
• tuition reimbursement & loan repayment assistance
• paid parental leave
• paid onsite parking
• commuter subsidy

Before you apply

• Candidates must reside within a commutable distance of the office to be considered

About the company

Genetix Biotherapeutics is pursuing curative gene therapies. The company is composed of doers, thinkers and collaborators who embrace values of innovation, diversity, and radical care.