Onsite Manufacturing Shift Lead, GMP & Quality

Kindeva; Maryland Heights (MO); On-site; USD 85,000 - 130,000; Full time

Job summary

Kindeva seeks an Operations Lead to serve as the designated operational leader for an assigned manufacturing suite, coordinating daily execution to ensure safety, quality, and productivity. This role directs day-to-day manufacturing activities and acts as the primary contact for production execution within the area.

The position emphasizes frontline leadership, documentation oversight, and escalation of issues impacting safety, quality, delivery, or productivity, with growth opportunities into

Qualifications

• Bachelor's degree or higher in a related field with manufacturing experience.
• Experience working in a regulated manufacturing environment.
• Ability to coordinate work activities and influence others.
• Strong communication, organizational, problem-solving, and decision-making skills.
• Ability to manage multiple priorities while maintaining safety, quality, and production requirements.

Responsibilities

• Lead execution of room activities to achieve safety, quality, and production objectives.
• Assign personnel, set priorities, and align workflow to maintain continuity of operations.
• Direct shift activities during planned downtime to sustain room readiness.
• Provide day‑of‑shift leadership for all Drug Product personnel working in the room.
• Address operational resistance, resource constraints, or execution barriers promptly and elevate as needed to protect shift performance.
• Lead effective shift handovers and communicate room status and risks clearly to incoming/outgoing leads.
• Maintain ownership of documentation and ensure records are complete and review‑ready in real time.
• Monitor training status and qualifications to ensure proper work assignment.
• Promote safety and quality by adhering to GMP/SOP requirements and escalating issues as needed.

Skills

Leadership

Communication

Problem-solving

Organizational skills

Decision-making

Multitasking

Regulatory understanding

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 seeks an Operations Lead to serve as the designated operational leader for an assigned manufacturing suite, coordinating daily execution to ensure safety, quality, and productivity. This role directs day-to-day manufacturing activities and acts as the primary contact for production execution within the area.

The position emphasizes frontline leadership, documentation oversight, and escalation of issues impacting safety, quality, delivery, or productivity, with growth opportunities into