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