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.