Production Operations Lead - US

Kindeva•Maryland Heights, MO

22h•Onsite

About The Position

The Operations Lead is the designated operational leader for an assigned manufacturing suite, coordinating daily execution to ensure safe, compliant, and efficient operations. The role provides frontline leadership through workforce coordination, operational decision-making, problem solving, documentation oversight, and escalation of issues that could affect safety, quality, delivery, or productivity. The Operations Lead directs day-to-day manufacturing activities and is the primary point of contact for production execution in the assigned area. The position is accountable for coordinating work and maintaining operational performance, but does not have formal responsibility for employee performance management, discipline, attendance management, employee relations, or other supervisory duties. Assigned team members execute tasks under the Operations Lead’s direction, while Supervisors retain responsibility for people-management matters. Success is measured by operational performance, quality and compliance outcomes, effective communication, workforce coordination, and maintaining execution standards in the manufacturing suite. The role may suit experienced manufacturing leaders, production colleagues ready for expanded responsibility, or individuals developing toward future operational leadership roles.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Operations Management, Business, or a related field and at least 2 years of manufacturing experience; OR an Associate degree and at least 4 years of manufacturing experience; OR a High School Diploma/GED and at least 6 years of manufacturing experience.
Experience working in a regulated manufacturing environment.
Demonstrated ability to coordinate work activities, influence others, or provide informal leadership within a team environment.
Strong communication, organizational, problem-solving, and decision-making skills.
Ability to manage multiple priorities while maintaining safety, quality, and production requirements.
Working knowledge of manufacturing documentation practices and procedural compliance.

Nice To Haves

Experience in pharmaceutical, biotechnology, medical device, sterile injectable, aseptic manufacturing, or combination product assembly operations.
Experience leading projects, work groups, shift activities, production teams, or manufacturing operations.
Experience directing daily manufacturing activities and coordinating resources to achieve production objectives.
Experience in a unionized manufacturing environment.
Knowledge of Good Manufacturing Practice (GMP) requirements, batch record review, deviation management, and quality systems.
Experience with Lean Manufacturing, Operational Excellence, Six Sigma, or continuous improvement methodologies.
Previous experience in a Lead, Senior Operator, Supervisor, Military Leadership, technical leadership, or equivalent operational leadership role.

Responsibilities

Lead execution of room activities during the shift to achieve safety, quality, and production objectives.
Assign personnel, set priorities, and align workflow to maintain operational continuity and effective use of staffing.
Direct activities during planned downtime, including sanitization, restocking, and preparation for upcoming operations.
Provide day-of-shift leadership for Drug Product personnel working in the room, including cross-shift and overtime support.
Address operational resistance, resource constraints, and execution barriers; escalate as needed to protect shift performance.
Lead shift handovers that communicate room status, open issues, priorities, and risks to continuity.
Participate in leadership exchange meetings and ensure critical information is transferred to incoming and outgoing leads.
Maintain operational continuity through timely communication, accurate documentation, and escalation of unresolved issues.
Own documentation executed during the shift and ensure records are complete, accurate, and review-ready in real time.
Review batch records in process on the production floor and resolve documentation gaps before personnel leave the area whenever possible.
Use downtime to review records, confirm attachments, and close near-complete documentation; coordinate follow-through with incoming leads when needed.
Monitor team training status and individual qualifications to ensure work is appropriately assigned.
Identify training risks and elevate gaps that could affect compliance, execution, or room readiness.
Promote safety and quality by ensuring adherence to SOPs, GMP requirements, and batch record expectations in the aseptic environment.
Identify, respond to, and promptly escalate safety concerns, compliance risks, downtime events, and quality issues.
Notify leadership when line-down conditions or other disruptions threaten shift performance or product quality.
Support deviation identification, documentation, and follow-up, escalating repeated or significant compliance issues.
Address day-to-day execution issues within the room and escalate employee-relations or interpersonal matters to the Supervisor.
Partner with leadership on matters requiring formal supervisory action.