Production Operations Lead - US
About The Position
The 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 productivity. The 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 duties.
Requirements
- Bachelor's 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 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.
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 use of available staffing.
- Direct shift activities during planned downtime to sustain room readiness, including sanitization, restocking, and preparation for upcoming operations.
- Provide day-of-shift leadership for all Drug Product personnel working in the room, including cross-shift and overtime support.
- Address operational resistance, resource constraints, or execution barriers promptly and escalate as needed to protect shift performance.
- Lead effective shift handovers that communicate room status, open issues, operational priorities, and risks to continuity.
- Participate in leadership exchange meetings and ensure critical information is transferred clearly to incoming and outgoing leads.
- Maintain continuity of operations through timely communication, accurate documentation, and clear escalation of unresolved issues.
- Maintain ownership of documentation executed during the shift and ensure records are complete, accurate, and review-ready in real time.
- Perform in-process batch record review on the production floor and resolve documentation gaps before personnel leave the area whenever possible.
- Use available downtime strategically to review records, confirm required attachments, and close near-complete documentation.
- Coordinate with incoming leads when documentation requires follow-through beyond the current shift.
- Monitor team training status and maintain awareness of individual qualifications to ensure work is assigned appropriately.
- Identify training risks proactively and elevate gaps that could affect compliance, execution, or room readiness.
- Promote a culture of safety and quality by ensuring adherence to SOPs, GMP requirements, and batch record expectations within the aseptic environment.
- Identify, respond to, and escalate safety concerns, compliance risks, downtime events, and quality issues in a timely manner.
- Notify leadership promptly when line-down conditions or other operational disruptions threaten shift performance or product quality.
- Support deviation identification, documentation, and follow-up, including escalation of repeated or significant compliance issues.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
