Job Description

Summary

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

Key Responsibilities

Detailed Scheduling (Aseptic Drug Product (ADP) Projects and Routine Production)

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

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’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.

Key Competencies

• 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

Key Performance Indicators

• Schedule adherence and OTIF performance for ADP projects and routine production
• Reduction in cycle times, downtime, and schedule variability
• Effective Tier 2 and cross-functional meeting outcomes (actions closed, decisions made, risks mitigated)
• On-time validation and launch milestones
• Improvements in capacity utilization and right-first-time execution

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between $98,700 and $183,300/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon

joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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