GMP Operations Lead

GMP Operations Lead

Position Summary

VintaBio is seeking a GMP Operations Lead to join our Technology & Manufacturing team. This team is responsible for technology development, process development, and both non-GMP and GMP manufacturing of viral vector products.

This is a hands-on leadership role for an experienced professional with deep expertise in upstream or downstream viral vector manufacturing within a GMP environment. The GMP Operations Lead serves as both a technical leader and people leader, overseeing GMP readiness, manufacturing execution, post-production activities, and continuous process improvement while managing a small team of scientists.

The ideal candidate combines strong technical expertise with a passion for operational excellence, cross-functional collaboration, and team development. This individual will help drive successful GMP manufacturing campaigns while ensuring compliance, quality, and operational efficiency.

Essential Responsibilities

GMP Operations & Manufacturing Leadership

• Lead and coordinate all MSAT-owned GMP pre-production activities, including batch record authoring, material readiness, scheduling, planning, and manufacturing preparation. 
• Oversee on-the-floor execution of GMP manufacturing campaigns and lead the team responsible for hands-on manufacturing activities. 
• Manage GMP post-production activities, including deviations, batch record review and closure, documentation, data analysis, trending, reporting, and CAPA implementation. 
• Maintain and continuously improve MSAT SOPs and supporting GMP documentation. 
• Coordinate GMP training activities for MSAT team members to ensure readiness and compliance. 
• Lead MSAT-owned activities supporting Aseptic Process Simulations (APS). 
• Partner with Process Development and Manufacturing teams to ensure successful scale-up and seamless transfer into GMP production. 
• Develop and implement tools to support process risk assessments, failure mode analyses, and other GMP readiness activities. 
• Establish and monitor key performance indicators (KPIs) to measure operational performance and drive continuous improvement. 
• Develop and maintain GMP readiness trackers to provide visibility across cross-functional teams. 
• Collaborate closely with Quality Control, Quality Assurance, Supply Chain, Facilities, Manufacturing, and other internal partners to ensure successful execution of GMP manufacturing campaigns. 

Team Leadership

• Lead, coach, mentor, and develop a small team of scientists within the Technology & Manufacturing organization. 
• Foster a collaborative, inclusive, and high-performing team environment that supports employee engagement and professional growth. 
• Provide regular coaching, performance feedback, and development opportunities. 
• Support hiring, onboarding, training, and retention of team members. 
• Promote a culture of continuous improvement, accountability, adaptability, and operational excellence. 

Additional Responsibilities

• Perform other related duties as assigned. 

Qualifications

Required Qualifications

• Bachelor's degree in Chemical Engineering, Biological Engineering, Biotechnology, Biology, Biochemistry, or a related scientific discipline. 
• Minimum experience requirements: 
  • Bachelor's degree with 6+ years of relevant industry experience 
  • Master's degree with 4+ years of relevant industry experience 
  • PhD with 2+ years of relevant industry experience 
• Demonstrated experience supporting GMP manufacturing of viral vector products. 
• Strong expertise in either upstream or downstream viral vector processing. 
• Deep understanding of GMP manufacturing, compliance requirements, and documentation practices. 
• Experience with process execution, experimental design, data analysis, and technical problem solving. 
• Strong organizational, communication, and cross-functional collaboration skills. 
• Proven ability to lead projects, influence stakeholders, and successfully manage competing priorities. 

Preferred Qualifications

• Master's or PhD in a relevant scientific discipline. 
• Previous experience leading or mentoring technical teams. 
• Experience supporting commercial-scale manufacturing or late-stage biologics. 
• Experience implementing operational improvements, KPI development, or Lean/continuous improvement initiatives. 

Technical Skills

• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) 
• Experience with Microsoft Visio 
• Familiarity with data analysis and visualization tools 
• Experience working within GMP documentation systems is preferred 

Why Join VintaBio?

At VintaBio, you'll have the opportunity to work alongside talented scientists and manufacturing professionals who are advancing next-generation gene therapy manufacturing. You'll play a key role in bringing innovative therapies closer to patients while helping build scalable GMP operations in a collaborative, science-driven environment.