Director, Technical Operations
About The Position
The Director of Technology Operations is a strategic and technical leadership role responsible for providing cross-functional operational and technical support for sterile injectable manufacturing operations within a contract development and manufacturing organization (CDMO). This role serves as a key liaison between Operations, Quality, MSAT, Engineering, Validation, Supply Chain, and Client Services to ensure reliable commercial manufacturing support, rapid investigation resolution, successful technology transfers, and continuous process improvement. Reporting directly to Operations leadership, the Director of Technology Operations will lead technical operational initiatives supporting aseptic manufacturing, filling, visual inspection, packaging, and associated support systems while ensuring compliance with current GMP regulations and client expectations.
Requirements
- 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.
- Strong understanding of: 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.
Responsibilities
- Provide technical leadership and operational support for commercial sterile injectable manufacturing operations.
- Serve as the primary technical escalation point for manufacturing issues impacting safety, quality, delivery, or cost.
- Partner closely with Manufacturing, Quality, and MSAT teams to ensure robust and compliant operations.
- Support daily production activities with rapid troubleshooting and risk-based decision-making.
- Drive operational excellence initiatives focused on throughput, efficiency, right-first-time performance, and deviation reduction.
- Lead and support complex manufacturing investigations, including deviations, OOS/OOT events, sterility assurance concerns, and equipment/process failures.
- Ensure investigations are scientifically sound, timely, and compliant with regulatory expectations.
- Facilitate root cause analysis using structured problem-solving methodologies.
- Oversee development and implementation of effective CAPAs to prevent recurrence.
- Support inspection readiness and regulatory responses related to operational investigations.
- Provide technical oversight for commercial product lifecycle support including: Process performance monitoring, Yield optimization, Batch record improvements, Change controls, Campaign management.
- Collaborate with Program Management to support customer communications and issue resolution.
- Support successful execution of manufacturing campaigns and schedule adherence.
- Support new product introductions, process transfers, and scale-up activities for sterile injectable products.
- Collaborate with MSAT and Validation teams on process qualification activities including: Media fills / APS PPQ, Cleaning validation, Equipment qualification.
- Ensure operational readiness for new technologies, products, and equipment implementation.
- Build strong partnerships across Operations, Quality, Engineering, Validation, and Supply Chain.
- Lead cross-functional technical review meetings and operational governance forums.
- Mentor technical operations staff and develop organizational technical capabilities.
- Promote a culture of accountability, compliance, continuous improvement, and teamwork.
- Identify opportunities for operational optimization and implementation of Lean manufacturing principles.
- Support data-driven performance metrics and KPI development.
- Ensure compliance with: FDA, EMA, ICH, cGMP, Annex 1, Data Integrity requirements.
- Participate in internal audits, client audits, and regulatory inspections.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
