Aseptic Manufacturing Shift Leader — Operations & Compliance

Kindeva-Drug-Delivery-Careers; St. Louis (MO); On-site; USD 85,000 - 115,000; Full time

Job summary

Kindeva Drug Delivery is seeking an Operations Lead to coordinate daily manufacturing execution in a compliant, safe environment. You will direct shift activities, manage staffing, and ensure timely handovers, documentation, and batch record quality.

You will monitor training, escalate safety and quality risks, and drive continuous improvement while maintaining production continuity across the assigned suite within a regulated facility.

Qualifications

• Institutional knowledge of manufacturing processes and GMP requirements.
• Experience coordinating work activities and influencing team members.
• Ability to manage multiple priorities while maintaining safety and quality.

Responsibilities

• Lead shift execution to meet safety, quality, and production goals.
• Assign personnel, priorities, and workflow to maintain operations.
• Direct shift activities during downtime to keep room ready.
• Provide day-of-shift leadership for Drug Product personnel.
• Escalate issues impacting shift performance or product quality.
• Lead effective shift handovers and document status and risks.
• Maintain real-time documentation and batch records accuracy.
• Coordinate with incoming leads for follow-through on docs.
• Monitor training status and ensure qualification coverage.
• Identify safety, compliance, and quality risks and escalate promptly.

Skills

Shift leadership

Cross-functional coordination

Excellent communication

Problem solving

Decision making

Education

Bachelor's degree in Engineering, Life Sciences, Operations Management, Business, or related field

Associate degree with 4+ years of manufacturing experience

High School Diploma/GED with 6+ years of manufacturing experience

Job description

Kindeva Drug Delivery is seeking an Operations Lead to coordinate daily manufacturing execution in a compliant, safe environment. You will direct shift activities, manage staffing, and ensure timely handovers, documentation, and batch record quality.

You will monitor training, escalate safety and quality risks, and drive continuous improvement while maintaining production continuity across the assigned suite within a regulated facility.