GMP Operations Lead

GMP Operations Lead Position Summary Vinta. Bio 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 Vinta.

Bio? At Vinta. Bio, 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.