Production Manager

Position Summary

The Production Manager is responsible for leading sterile manufacturing operations for products. This role ensures production is performed safely, efficiently, and in compliance with cGMP, FDA regulations, and internal quality standards. The role also supports startup, scale-up, and continuous improvement activities in a regulated environment.

Department: Production

Location: Boca Raton, FL

Salary Range: $85,000 – $95,000

Key Responsibilities

• Lead daily sterile manufacturing operations and coordinate with supporting functions such as QA, warehouse, and supply chain.
• Manage and develop production teams, including operators and supervisors.
• Ensure compliance with SOPs, aseptic practices, safety standards, and regulatory requirements.
• Oversee manufacturing processes including formulation, filtration, filling, and sealing.
• Support validation activities, batch record review, and process optimization.
• Oversee equipment qualification activities (DQ, IQ, OQ, PQ).
• Support sterilization cycle development and qualification activities.
• Identify and mitigate production risks in collaboration with Quality teams.
• Work closely with QA and Validation teams to ensure compliance across all processes.
• Support regulatory inspections and audits.
• Drive CAPA initiatives and continuous improvement efforts.
• Investigate deviations, failures, and OOS results and implement corrective actions.
• Ensure ongoing compliance with regulatory and quality requirements.

Qualifications

• Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.
• 10+ years of experience in pharmaceutical manufacturing.
• Strong experience in sterile manufacturing environments
• Hands-on experience in aseptic processing, validation, and GMP-compliant operations.
• Knowledge of FDA regulations, cGMP guidelines, and quality systems.

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