About this role
Lead strategic capital projects that support the manufacturing network’s ability to deliver potent neuroscience products to patients. Own end-to-end project success across EHS, scope, schedule, cost, quality, and compliance while partnering closely with ME&C and Quality throughout development.
Key Responsibilities
- Lead single point responsibility for project objectives including EHS, scope, schedule, cost, quality and compliance
- Manage all phases of project execution with top-tier performance of external partners
- Drive EHS performance including construction safety and ensure no impact to existing facilities
- Control costs with capital/expense planning, LBE, and estimates to complete
- Monitor KPIs, manage risks, and lead sourcing/contract negotiations with procurement
Technical Overview
Applies deep knowledge of drug product manufacturing execution, with in-depth exposure to Aseptic and Sterile Manufacturing technologies such as multi-format Drug Product filling lines and a lyophilizer (plus small volume cytotoxic filling advantage). Drives execution governance using KPIs, risk management, and value engineering to improve efficiency and timelines.
Ideal Candidate
The ideal candidate is a Senior Project Manager with 10+ years of engineering/project/operations leadership experience supporting drug product manufacturing. They have strong EHS ownership, risk management discipline, financial acumen for capital projects, and experience managing complex execution from concept through delivery with KPIs and steering committee governance.
Must-Have Skills
EHS and Engineering Policies and procedures complianceManage and be responsible for all phases of project executionRisk management and mitigation with escalation to steering committee when requiredDemonstrate exceptional financial acumen and control over costsMonitor and measure project progress and performance through a set of KPIsStrategic sourcing involvement including assisting with contract negotiationsManage scope and schedule creep and dispute resolution
Nice-to-Have Skills
In-depth technical and operational expertise in manufacturing technologies related to Aseptic and Sterile ManufacturingExpertise in multi-format Drug Product filling linesLyophilizer experienceSmall volume cytotoxic product filling experience
Tools & Platforms
KPIs (key performance indicators)
Required Skills
EHSEnvironmentHealth and Safetyproject objectivesScopeScheduleCostQualityCompliancerisk managementsteering committeeLBEvalue engineeringstrategic sourcingcontract negotiationsscope and schedule creepdispute resolutionKPIkey performance indicatorsAseptic and Sterile Manufacturingaseptic filling lineslyophilizermulti-format Drug Product filling linessmall volume cytotoxic product fillingconstruction safetyengineering policies and procedures
Hard Skills
EHS performance managementEngineering Policies and procedures complianceConstruction safetyDesign within scope boundariesProject execution across all phasesRisk management and mitigationSteering committee escalationFinancial acumenCapital and expense spend planningLBEEstimates to complete (ETC)Value engineeringValue engineeringDispute resolutionScope and schedule creep managementStrategic sourcingContract negotiationsKPI monitoringProject progress and performance measurementAseptic and Sterile Manufacturing manufacturing technologies (in-depth technical expertise)Multi-format Drug Product filling linesLyophilizerSmall volume cytotoxic product fillingAseptic filling lines (advantage)
Soft Skills
Single point responsibilityTop-tier performance leadershipCross-functional collaborationCommunication across all levelsPresenting to steering committeesStakeholder engagementInnovation and idea exchangeAgility in executionLeadership of consultants and external partners
Keywords for Your Resume
Sr. Project ManagerSenior Project ManagerProject ManagerProject objectivesEHSEnvironmentHealth and SafetyScopeScheduleCostQualityComplianceProject executionRisk managementSteering committeeLBEvalue engineeringdispute resolutionstrategic sourcingcontract negotiationsKPIkey performance indicatorsAseptic and Sterile Manufacturingaseptic filling lineslyophilizermanufacturing technologiesmulti-format Drug Product filling linessmall volume cytotoxic product fillingBSEngineeringEHS performanceconstruction safetyengineering policies and proceduresscope and schedule creep
Deal Breakers
Must have 10+ years of experience as an Engineering Leader/Projects/Operations Leader across multiple Drug product operations, Must be able to demonstrate EHS and Engineering Policies compliance and drive construction safety performance
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