GMP Operations LeadPosition SummaryVintaBio 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 ResponsibilitiesGMP 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.
QualificationsRequired 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
