Production Scheduler in Nashville, Tennessee at August Bioservices
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Job Description
The Production Scheduler is responsible for developing and maintaining the detailed, day-to-day production schedule across sterile manufacturing suites — including dispensing, formulation, aseptic filling, visual inspection, and packaging. This role translates the master production schedule and client demand into an executable schedule that accounts for cleanroom availability, personnel availability/competencies, equipment changeovers, campaign sequencing, and material readiness. The Scheduler works cross-functionally with Manufacturing, Quality, Supply Chain, Warehouse, Facilities/Engineering, and Client Services to maximize suite utilization while protecting product quality, batch genealogy, and client commitments.
This is a highly detail-oriented, execution-focused role suited to someone comfortable balancing competing priorities in a highly regulated, capacity-constrained aseptic manufacturing environment.
- Detailed Scheduling & Execution
- Build and maintain rolling detailed production schedules (daily/weekly/monthly horizons) for dispensing, compounding, filling lines, visual inspection, and packaging suites.
- Sequence batches to minimize changeover time, cleaning/sanitization cycles, and gowning transitions while respecting product segregation
- Adjust schedules in real time in response to deviations, equipment downtime, material delays, QC hold times, or client priority changes; communicate impacts promptly.
- Capacity & Constraint Management
- Model suite, equipment, and labor capacity constraints (fill line speeds, autoclave loads, fill line availability, inspection throughput) to identify bottlenecks.
- Partner with Manufacturing and Engineering on preventive maintenance and calibration scheduling to minimize disruption to production.
- Flag capacity gaps or overbooking risks to leadership with proposed mitigation options.
- Cross-Functional Coordination
- Align detailed schedules with the Master Production Schedule (MPS), demand plan, and client-committed delivery dates.
- Coordinate with Warehouse/Materials Management to confirm raw material, component (vials, stoppers, syringes), and primary packaging availability ahead of scheduled batches.
- Work with QA to sequence batch record issuance, in-process testing, and release timelines into the schedule.
- Support Client Services/Program Management with schedule visibility, risk communication, and root-cause input for schedule adherence metrics.
- Systems & Data Integrity
- Maintain accurate schedule data in ERP system
- Ensure batch numbers, lot genealogy, and campaign sequencing are correctly reflected across scheduling and quality systems.
- Generate schedule adherence, OTIF (on-time-in-full), and utilization reports for operations reviews.
- Continuous Improvement & Compliance
- Support root cause analysis for schedule misses and participate in CAPA activities related to planning/scheduling.
- Operate within cGMP, data integrity, and site SOP requirements at all times; complete required training.
- Participate in S&OP (Sales & Operations Planning) and tiered daily management meetings, providing schedule status and risk escalation.
- Bachelor's degree in Supply Chain, Operations Management, Engineering, Life Sciences, or related field (or equivalent combination of education and experience).
- 3+ years of production scheduling/planning experience in pharmaceutical, biotech, or sterile/aseptic manufacturing; CDMO experience strongly preferred.
- Working knowledge of aseptic processing concepts (isolators/RABS, cleanroom classifications, media fills, autoclave cycles).
- Experience with ERP and/or advanced planning/scheduling (APS) systems (SAP, Oracle, JDE, PlanetTogether, Kinaxis, or similar).
- Strong Excel skills (pivot tables, lookups); experience with scheduling/Gantt tools.
- Solid understanding of cGMP, batch record processes, and regulated manufacturing documentation.
- Excellent organizational skills and ability to manage multiple, shifting priorities under time pressure.
- Strong cross-functional communication skills; comfortable presenting schedule risk to operations leadership.