Gene Therapy Manufacturing Lead

REGENXBIO is seeking a Gene Therapy Manufacturing Lead to establish its internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability. The GTM Lead will lead the establishment of new processes, procedures, and ways of working, and perform manufacturing process related tasks and unit operations within the Upstream, Downstream, and/or Fill Finish areas.

Requirements

• Bachelor’s degree OR Associate’s degree/High School Diploma or equivalent with relevant cGMP experience
• 6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations
• Excellent oral and written communication skills with strong technical writing ability
• Excellent teaching and facilitation skills for on-the-job training delivery
• Strong organizational and leadership skills
• Strong experience in GMP quality systems, including deviation root cause analysis tools
• Ability to apply continuous improvement and operational excellence strategies within a manufacturing organization
• Ability to think critically in regard to problem solving and troubleshooting
• Ability to work collaboratively with colleagues in a results-driven, team-oriented environment
• Strong subject matter expertise in GMP Manufacturing operations, processes and equipment for US, DS, and/or FF areas
• Experience in aseptic fill finish and AAV manufacturing/viral transfection
• Experience in supporting facility start-up, commissioning and qualification activities
• Hands on experience with single-use technologies and systems
• Experience using DeltaV PCS system

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Retirement plan with 401(k) match
• Summer hours