Director, Production Operations

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

In this role, you are responsible for leading the aseptic filling operations and technical services within the Brentwood sterile injectable filling facility. The primary duties are to assure operational success and drive best-in-class capabilities, and performance related to safety, quality, compliance, and operational execution. Scope of responsibilities include oversight of production operations, facility maintenance, utilities, engineering, automation, and computerized maintenance management systems (CMMS).  This role includes ensuring the reliability and operational excellence of aseptic filling equipment and processes. The successful candidate will drive system and culture transformation to enhance equipment reliability and manufacturing efficiency while ensuring compliance with global regulatory requirements.

Aseptic Filling Operations:

• Accountable for execution of the aseptic filling plan with adherence to Good Manufacturing Practices (GMP) and regulatory requirements; includes financial performance, OTIF from BW, and budget management.
• Manage technical setup, operation, and maintenance of sterile injectable filling equipment to ensure continuous and efficient operation.
• Lead operational improvements to increase right first time, efficiency, reduce downtime, and optimize filling operations.
• Collaborate with cross-functional teams to ensure compliance with FDA and international regulations and best practices for aseptic manufacturing.
• Drive the safety culture within the operation.

Technical Services:

• Lead and manage facilities maintenance and plant utilities, including both clean and non-clean utilities to assure equipment reliability through proper and timely execution of preventive and corrective maintenance plans and programs.
• Support manufacturing engineers and automation teams to optimize equipment and utilities performance and reliability.
• Ensure seamless operation and enhancement of the site’s Computerized Maintenance Management System (CMMS) to support proactive maintenance strategies.
• Drive reliability-centered maintenance programs to enhance uptime and performance of critical equipment.

Leadership and Compliance:

• Work as an integral member of the site management team and extended ST Louis area leadeship team, effectively interfacing with peers and direct reports to deliver on key objectives and established initiatives.
• Provide operational metrics, budgeting, planning, and organizational direction.  Maintain alignment with other manufacturing sites through shared knowledge and data
• Manage all aspects of direct report development, including career planning, performance management, training, priority and objectives-setting, and enhancing expertise in aseptic manufacturing and engineering.
• Foster a culture of manufacturing and technical excellence, innovation, continuous improvement, and accountability while improving right first time performance
• Drive organizational transformation to improve equipment reliability and operational effectiveness.
• Ensure compliance with all applicable regulatory requirements, including FDA, EMA, and other global health authority standards.

Basic Qualifications

• Minimum of 10 years of experience in managerial or senior leadership roles within aseptic pharmaceutical manufacturing.
• Strong background in equipment reliability improvement and operational turnaround initiatives.
• Demonstrated experience in transforming maintenance and engineering systems and culture.
• In-depth knowledge of FDA and international aseptic injectable manufacturing regulations.
• Bachelor’s degree in engineering, pharmaceutical sciences, or a related technical field; advanced degree preferred.
• Expertise in leveraging automation, technical manufacturing processes, and filling equipment qualifications and modifications.
• Proven ability to lead cross-functional teams and drive performance improvements in a regulated environment. 

Preferred Qualifications: 

• Experience in implementing digital transformation in manufacturing and maintenance operations.
• Experience working with ERP and / or deploying ERP systems into a manufacturing site

California residents should review our Notice for California Employees and Applicants before applying. 
 
 

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!