Production Scheduler
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
