Detailed Scheduler and Operations Governance

Novartis AG•Durham, NC

45d•Onsite

About The Position

We are seeking a seasoned operations leader to serve as Manager overseeing detailed scheduling and acting as Chief of Staff for the Aseptic Drug Product (ADP) program. This dual-role position is pivotal to orchestrating complex, multi-stream schedules across ADP projects and routine GMP production, while enabling effective governance, communication, and execution through structured tiered meeting systems (including Tier 2). The ideal candidate brings deep experience in end-to-end manufacturing scheduling, cross-functional alignment, and operational leadership within aseptic environments. About the Role Location: This role is located in Durham, NC #LI-Onsite This position is on-site 5 days a week with no opportunity to work a hybrid schedule. Relocation assistance is not available for this position

Requirements

Bachelor's 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.

Responsibilities

Build, own, and continuously 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 (e.g., formulation, filtration, sterilization, filling, visual inspection, packaging) and batch sizes Sterility assurance requirements, environmental monitoring, and cleaning cycles Distinct project phases and critical-path activities for parallel ADP projects
Coordinate scenario planning and "what-if" 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
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