Manager, Production Manufacturing

Job Description

Summary

The Production & Manufacturing Manager supports the timely manufacturing of parenteral products in an aseptic environment according to Current Good Manufacturing Practice (cGMP) standards. This role is responsible for overseeing all manufacturing activities during a shift within a sterile filling business unit.

Key responsibilities include ensuring compliance with all relevant regulations and procedures, maintaining Current Good Documentation Practices (cGDP), and participating in training and continuous improvement initiatives to enhance production efficiency.

The Manager may oversee the following departments:

• Glass Wash, Aseptic Filling & Capping, and Lyophilization teams
• Support Supervisor (Compounding and Equipment Preparation)
• Equipment Mechanic
• Production Control Specialist
• Set-up Mechanic

All shift activities fall under the manager’s supervision.

Essential Duties & Responsibilities

• Manage and coordinate all manufacturing activities during the assigned shift.
• Compile and report shift information and line status data accurately and timely to support teams and the oncoming shift management team.
• Ensure and enforce compliance with cGMPs, site-specific policies, and procedures.
• Serve as the shift representative to internal support groups and assist the customer service representative with external customers.
• Maintain and report on Key Performance Indicators (KPIs).
• Provide professional development, mentoring, and succession planning for direct reports.
• Facilitate cross-functional training for shift members.
• Ensure adherence to the production schedule and monitor material consumption rates.
• Oversee and report on all safety incidents and quality deviations, conducting thorough investigations and timely reporting.
• Develop fluency in all functional areas of responsibility and coordinate resource sharing across teams/departments.
• Exhibit strong interpersonal communication skills, clearly conveying ideas and facts in a logical and concise manner.
• Read and interpret Standard Operating Procedures (SOPs) to ensure compliance.
• Maintain up-to-date training records.
• Perform additional duties as assigned.

Education & Experience

Required:

• Associate’s degree in Science, Business, Engineering, or a related field.
• Minimum 8 years of experience in pharmaceutical manufacturing or a relevant industry.
• Minimum 4 years of experience in a leadership role.

Preferred:

• Bachelor’s degree in Science, Business, Engineering, or a related field.
• Minimum 6 years of experience in pharmaceutical manufacturing or a relevant industry.