Sterile Manufacturing Manager
Accentuate Staffing is partnering with a leading pharmaceutical manufacturing company to hire a Sterile Manufacturing Manager. This is a key leadership role responsible for overseeing aseptic manufacturing operations and driving performance, compliance, and team development within a highly regulated cGMP environment. This role is ideal for someone with strong aseptic processing expertise, proven people leadership, and a passion for building high-performing teams while maintaining the highest standards of quality and compliance.
Responsibilities:
- Lead and manage sterile manufacturing operations, including formulation, filling, and aseptic processing
- Oversee daily production activities to ensure alignment with cGMP, FDA, and regulatory requirements
- Drive operational performance, including throughput, efficiency, and right-first-time execution
- Provide leadership, coaching, and development for manufacturing staff and supervisors
- Partner cross-functionally with QA, QC, Engineering, and Validation teams
- Support and lead investigations, including deviations, CAPAs, and root cause analysis
- Ensure inspection readiness and actively participate in regulatory audits
- Identify and implement continuous improvement initiatives across operations
Requirements:
- Bachelor’s degree in a scientific or engineering discipline
- 7+ years of pharmaceutical manufacturing experience, with a strong focus on aseptic/sterile operations
- Prior leadership experience managing teams in a manufacturing environment
- Strong knowledge of cGMP, FDA regulations, and aseptic processing standards
- Experience with deviations, CAPA, and regulatory inspections
- Proven ability to lead teams, drive performance, and operate in a fast-paced environment
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