Production Operations Lead US

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe Operations Lead serves as the designated operational leader for an assigned manufacturing suite and is responsible for coordinating daily execution to ensure safe compliant and efficient operations. This role provides frontline leadership through workforce coordination operational decision-making problem solving documentation oversight and escalation of issues that could impact safety quality delivery or Operations Lead directs day-to-day manufacturing activities and serves as the primary point of contact for production execution within the assigned area. While accountable for coordinating work and maintaining operational performance this position does not have formal responsibility for employee performance management discipline attendance management or other supervisory Leadership & Operational ExecutionLead execution of all room activities during the shift to achieve safety quality and production personnel set priorities and align workflow to maintain continuity of operations and effective use of available shift activities during planned downtime to sustain room readiness including sanitization restocking and preparation for upcoming day-of-shift leadership for all Drug Product personnel working in the room including cross-shift and overtime operational resistance resource constraints or execution barriers promptly and escalate as needed to protect shift Handover & Operational CommunicationLead effective shift handovers that communicate room status open issues operational priorities and risks to in leadership exchange meetings and ensure critical information is transferred clearly to incoming and outgoing continuity of operations through timely communication accurate documentation and clear escalation of unresolved & Batch Record QualityMaintain ownership of documentation executed during the shift and ensure records are complete accurate and review-ready in real in-process batch record review on the production floor and resolve documentation gaps before personnel leave the area whenever available downtime strategically to review records confirm required attachments and close near-complete with incoming leads when documentation requires follow-through beyond the current OversightMonitor team training status and maintain awareness of individual qualifications to ensure work is assigned training risks proactively and elevate gaps that could affect compliance execution or room training risks proactively and elevate gaps that could affect compliance execution or room Compliance & Quality EscalationPromote a culture of safety and quality by ensuring adherence to SOPs GMP requirements and batch record expectations within the aseptic respond to and escalate safety concerns compliance risks downtime events and quality issues in a timely leadership promptly when line-down conditions or other operational disruptions threaten shift performance or product deviation identification documentation and follow-up including escalation of repeated or significant compliance QualificationsBachelors degree in Engineering Life Sciences Operations Management Business or a related field with 2 years of manufacturing experience; OR Associate degree with 4 years of manufacturing experience; OR High School Diploma/GED with 6 years of manufacturing working in a regulated manufacturing ability to coordinate work activities influence others or provide informal leadership within a team communication organizational problem-solving and decision-making to manage multiple priorities while maintaining safety quality and production knowledge of manufacturing documentation practices and procedural QualificationsExperience in pharmaceutical biotechnology medical device sterile injectable aseptic manufacturing or combination product assembly operations.