Aseptic Manufacturing Shift Leader

Kindeva; Missouri; On-site; USD 90,000 - 130,000; Full time

Job summary

Kindeva Drug Delivery is seeking an Operations Lead to direct day‑to‑day manufacturing activities within a regulated aseptic environment. You will coordinate workforce, ensure safety, quality, and productivity, and serve as the primary operations contact for the assigned suite.

You will mentor Supervisors and line staff, oversee batch record quality, and ensure documentation is complete and compliant across shifts, mounting the path for future operational leadership opportunities.

Qualifications

• Bachelor's degree or higher with manufacturing experience and GMP exposure.
• Experience coordinating work activities and influencing others.
• Strong communication, organizational, problem-solving, and decision-making skills.
• Ability to manage multiple priorities while ensuring safety, quality and production.
• Working knowledge of manufacturing documentation practices and compliance.
• Experience in a regulated manufacturing environment.

Responsibilities

• Lead execution of shift activities to meet safety, quality and production goals.
• Assign personnel, set priorities, and align workflow to sustain operations.
• Direct downtime activities to maintain room readiness and readiness for upcoming work.
• Provide day-of-shift leadership for Drug Product personnel, including cross-shift support.
• Address operational barriers promptly and escalate when needed.
• Lead effective shift handovers and communicate room status and risks.
• Ensure clear documentation and escalation of unresolved issues.
• Maintain ownership of shift records and batch record quality in real time.
• Monitor training status and ensure staff qualifications are current.
• Identify safety/compliance issues and escalate to protect performance.
• Escalate line-down conditions affecting shift performance or product quality.
• Collaborate with Supervisors on employee relations and escalation matters.

Skills

Communication

Organizational skills

Problem-solving

Decision-making

Leadership

Prioritization

Documentation practices

Regulated environment

Education

Bachelor's degree in Engineering, Life Sciences, Operations Management, Business, or a 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 direct day‑to‑day manufacturing activities within a regulated aseptic environment. You will coordinate workforce, ensure safety, quality, and productivity, and serve as the primary operations contact for the assigned suite.

You will mentor Supervisors and line staff, oversee batch record quality, and ensure documentation is complete and compliant across shifts, mounting the path for future operational leadership opportunities.