Aseptic Production Operations Lead

Kindeva; St. Louis (MO); On-site; USD 70,000 - 90,000; Full time

Job summary

Kindeva is seeking an Operations Lead to serve as the designated operational leader for an assigned manufacturing suite. You will coordinate daily execution to ensure safe, compliant, and efficient operations and provide frontline leadership for production execution.

Responsibilities include shift leadership, documentation oversight, training monitoring, and escalation of issues affecting safety, quality, or productivity.

Qualifications

• Bachelor's degree or equivalent in a related field with manufacturing experience or an equivalent combination of education and experience.
• Experience in a regulated manufacturing environment and familiarity with SOPs, GMP requirements.
• Ability to coordinate work activities, influence others, and provide informal leadership within a team.

Responsibilities

• Lead execution of all room activities during the shift to achieve safety, quality, and production objectives.
• Assign personnel, set priorities, and align workflow to maintain continuity of operations and effective staffing.
• Direct shift activities during planned downtime to sustain room readiness and preparation for upcoming operations.
• Provide day-of-shift leadership for Drug Product personnel, including cross-shift and overtime support.
• Address operational resistance, resource constraints, or execution barriers promptly and elevate as needed to protect shift performance.
• Lead effective shift handovers communicating room status, priorities, and risks to continuity.
• Maintain documentation ownership, ensure records are complete and review-ready in real time.
• Monitor training status and ensure qualifications align with assigned work.

Skills

Leadership

Cross-functional coordination

Communication

Problem solving

Documentation

Education

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

Associate degree with 4+ years manufacturing experience

High School Diploma/GED with 6+ years manufacturing experience

Job description

Kindeva is seeking an Operations Lead to serve as the designated operational leader for an assigned manufacturing suite. You will coordinate daily execution to ensure safe, compliant, and efficient operations and provide frontline leadership for production execution.

Responsibilities include shift leadership, documentation oversight, training monitoring, and escalation of issues affecting safety, quality, or productivity.