Production Scheduler

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.

Responsbilities

• 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.

Qualifications

• 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).

Knowledge, Skills, & Abilities

• 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.