Director, Gene Therapy Manufacturing & Operations

Socket.dev

Germantown (MD)

On-site

USD 190,000 - 270,000

Full time

6 days ago

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Job summary

Socket.dev is seeking a Director, Gene Therapy Manufacturing, Drug Substance to lead and shape the current and future manufacturing teams for our clinical and commercial drug substance manufacturing, including project and site readiness, organizational design, and the establishment of operating rhythms, accountability, governance, culture, and performance standards.

The incumbent will lead tactical planning, cross-functional coordination with project management and MS&T, and activities required

Qualifications

Bachelor’s degree in Biology, Chemistry, Chemical Engineering, or related field.
10+ years of relevant cGMP experience in biologics, pharmaceutical or regulated manufacturing environments.
5+ years of people leadership experience in Manufacturing, Technical Operations, Quality Operations or Engineering.
Experience leading teams with direct and indirect reports; regulatory readiness knowledge.

Responsibilities

Lead manufacturing operations teams across production, quality, materials and support functions.
Generate production schedules, requirements, quality standards and ensure delivery commitments.
Direct responsibility for on-the-floor activities and real-time issue resolution.
Partner with MS&T for scale-up, tech transfer, implementation, and continuous improvement.
Ensure readiness plans and risk assessments are developed and executed.