Director, Technical Operations
On-site · St. Louis, Missouri, United States
Job Summary
Director, Technology Operations at Kindeva oversees cross-functional operational and technical support for sterile injectable manufacturing within a CDMO, serving as a primary technical escalation point and leading investigations, CAPA management, and technology transfers. Responsibilities include supporting aseptic manufacturing, packaging, filling, visual inspection, and related support systems; driving throughput and right-first-time performance; ensuring compliance with GMP requirements and regulatory expectations; coordinating with Operations, Quality, MSAT, Engineering, Validation, and Supply Chain; leading cross-functional reviews, governance forums, and mentoring technical staff; enabling successful manufacturing campaigns, change controls, and lifecycle support for commercial products; and supporting process qualification activities (Media fills/APS, PPQ, Cleaning validation, Equipment qualification) while maintaining inspection readiness and data integrity.
Required Qualifications
- 10+ years of experience in pharmaceutical manufacturing within sterile injectable and aseptic processing environments.
- 5+ years of leadership experience in Operations, MSAT, Technical Services, or Manufacturing Support roles.
- Strong experience supporting commercial aseptic manufacturing operations in a CDMO/CMO environment preferred.
- Demonstrated expertise in: Aseptic processing, Sterile filling operations, Contamination control, Investigations and CAPAs, Technology transfer, GMP compliance, Annex 1, Aseptic processing simulation (APS/media fills), Environmental monitoring, Sterility assurance, Process validation, Root cause investigations, Risk management principles.
- Experience with automated manufacturing systems and modern sterile manufacturing technologies preferred.
- Experience supporting isolator operations preferred.
- Experience with prefilled syringes, vials, or cartridges.
- Prior FDA, EMA, or client inspection support experience.
- California residents should review our Notice for California Employees and Applicants before applying.
Additional Requirements
- California residents should review our Notice for California Employees and Applicants before applying.
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