Detailed Scheduler and Operations Governance

Role Summary

Detailed Scheduler and Operations Governance role overseeing detailed scheduling and acting as Chief of Staff for the Aseptic Drug Product (ADP) program. Responsible for orchestrating complex, multi-stream schedules across ADP projects and routine GMP production, enabling governance, communication, and execution through structured tiered meeting systems (including Tier 2). Requires deep experience in end-to-end manufacturing scheduling, cross-functional alignment, and operational leadership within aseptic environments.

Responsibilities

• Detailed Scheduling (Aseptic Drug Product (ADP) Projects and Routine Production)
  • Build, own, and optimize an integrated master schedule spanning ADP tech transfer, qualification, validation, and launch activities; routine aseptic fill-finish production, changeovers, and campaign planning; equipment readiness, line availability, and preventive maintenance windows; material readiness (components, APIs, excipients), and supplier lead times; lab testing (IPC, QC), batch record execution, and QA release timelines; facilities/utilities constraints (HVAC, clean utilities), and capacity limits
  • Develop detailed finite schedules at the work-center level accounting for varying process trains, sterility assurance requirements, environmental monitoring, cleaning cycles, and distinct project phases and critical-path activities for parallel ADP projects
  • Coordinate scenario planning and ‚Äúwhat-if‚Äù analysis to balance dynamic priorities; evaluate trade-offs for accelerated project milestones vs. routine service levels; model impacts of deviations, line downtime, and supply delays on committed dates
• Establish And Manage Scheduling Standards And Cadence
  • Weekly finite scheduling updates and firm/frozen horizons
  • Clear scheduling rules, constraints, and escalation paths
  • KPI dashboards (schedule adherence, OTIF, cycle time, capacity utilization)
• Partner Cross-functionally To Secure Execution Readiness
  • Manufacturing, Engineering/Maintenance, Supply Chain, QC/QA, MSAT, HSE
  • Ensure synchronization of materials, documentation, personnel, and equipment
• Drive Digital Enablement And Data Accuracy
  • Maintain accurate master data, routings, and lead times in ERP/MES/APS tools
  • Implement scheduling automation, visualization, and exception management
• Lead Root Cause And Continuous Improvement For Schedule Performance
  • Analyze variances and bottlenecks; implement corrective and preventive actions
  • Standardize scheduling methods and governance across lines and products
• Operations Governance
  • Operate as the operational integrator and right hand to ADP leadership: translate strategic priorities into executable plans with clear owners, timelines, and metrics; prepare leadership readouts, decision briefs, and portfolio status updates
• Design and facilitate tiered meeting structures to drive discipline and alignment
  • Plan and lead Tier 2 daily/weekly syncs and cross-functional forums
  • Ensure agendas are outcomes-focused, data-driven, and time-boxed
• Enable Performance Management And Transparency
  • Curate dashboards for schedule health, capacity, right-first-time, and quality impacts
  • Establish cadence for KPI reviews, corrective actions, and accountability
• Orchestrate Risk Management And Escalation
  • Proactively surface constraints; run playbooks for recovery and re-baselining
  • Facilitate expedient, structured decision-making with clear trade-off framing
• Lead Communications And Stakeholder Engagement
  • Maintain clear updates for site leadership, program teams, and external partners
  • Standardize templates and artifacts (RACI, roadmaps, calendars, status packs)
• Support Workforce Planning And Readiness
  • Coordinate staffing plans, training schedules, and shift coverage aligned to demand
  • Partner with HR, Training, and EHS to support compliant, safe operations

Qualifications

• Bachelor‚Äôs degree in Engineering, Supply Chain, Operations Management, Life Sciences, or related field; advanced degree preferred.
• 8+ years in GMP manufacturing operations, with experience in detailed scheduling/planning for aseptic or highly regulated environments.
• Demonstrated experience managing complex, multi-product schedules across projects and routine production with variable processes and timelines.
• Proficiency with ERP/MES/APS tools and advanced scheduling techniques; strong data acumen and visualization skills.
• Proven ability to lead cross-functional teams and facilitate tiered meetings (including Tier 2) with disciplined follow-through.
• Strong understanding of validation lifecycles, tech transfer, and change control in aseptic operations.
• Excellent communication, stakeholder management, and decision-framing skills.
• Continuous improvement mindset; experience with Lean, Six Sigma, or similar methodologies.

Skills

• Strategic systems thinking with hands-on execution
• Analytical rigor and scenario planning
• Governance discipline and facilitation excellence
• Cross-functional influence and relationship building
• Resilience, prioritization, and adaptability in dynamic contexts
• Integrity, quality mindset, and compliance orientation

Education

• As listed in Qualifications

Additional Requirements

• Location: Durham, NC (on-site 5 days a week)
• Relocation assistance not available