Associate Manager, GMP Support (Tubing Assembly)
Core
Provide technical and operational leadership for tubing assembly activities supporting cGMP manufacturing operations for gene therapies.
Role type
Associate Manager, GMP Support (Tubing Assembly)
Builds
Tubing assemblies and manufacturing support infrastructure for gene therapy production
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Required skills
cGMP compliance, tubing assembly processes, technical documentation (SOPs, MPRs), quality system management (deviations, CAPAs, change controls), team leadership, cleanroom operations, inventory management, cross-functional collaboration
Preferred skills
biologics/gene therapy experience, single-use assembly design, MES/ERP systems, regulatory inspection support
Technologies
MES, ERP/MRP, electronic batch records, document management systems
Responsibilities
Lead and coordinate day-to-day tubing assembly activities; Serve as subject matter expert for tubing assembly processes; Lead design and implementation of tubing assemblies; Review and maintain technical drawings and GMP documentation; Own and lead deviations, CAPAs, and change controls; Troubleshoot assembly and process issues; Plan and assign daily activities; Provide technical direction and mentorship to team members; Manage assembly materials and inventory; Collaborate cross-functionally with Manufacturing, QA, Engineering, etc.; Identify opportunities for process improvements; Support regulatory inspections and audits; Adhere to cGMP requirements and cleanroom practices
Seniority
Manager, hands-on IC with team leadership