Senior Project Director, Aseptic Campus
Company Description
About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
Purpose: The Senior Project Director, Aseptic Campus will lead the planning, execution, and delivery of a >$1B greenfield capital project to developa state-of-the-artaseptic drug product manufacturing campus. The facility will include multipleasepticdrug product filling lines, formulation suites, utilities, warehousing, laboratories, and supporting infrastructure designed to meet global regulatory standards (FDA, EMA, and otherregulatoryagencies). Thisroleis responsible foroverall project governance, strategic decision-making, and delivery across engineering, procurement, construction, commissioning, qualification, and startup.Theincumbentwill drive transformational performance in delivery of Strategic projects throughaccelerated timelines taking advantage of digital technologies,adoption of best-in-class technology, cross-functional alignment with Operations and external functions, seamlessexecutionand delivery of projects withstakeholders.The incumbent will report to VP, Strategic Capital Deployment in the Operations Transformationorganization. Responsibilities: - Lead a team of project directors and managers to achieve the charter,prioritiesand milestones of strategic projects in various locations within the US.
- Provide executive leadership for the full lifecycle of a >$1B greenfield pharmaceutical manufacturing campus project.
- Establish andmaintainproject governance, reporting structures, and decision-making frameworks, ensuring continuous alignment with stakeholders
- Lead integrated project teams across engineering, construction, CQV, quality, manufacturing, supply chain, and regulatory functions.
- Serve as the primary interfacefor the projectwith executive leadership, steering committees, and key stakeholders.
- Develop and execute the master project plan including scope, schedule, cost, risk management,contractingand resource strategies.Responsibleto meetthe key intent of the projects best-in-classdesign,on time delivery,delivery of scope on or below budgetedcost andconformance toquality requirements.
- Ensure alignment of facility design with long-term manufacturing network strategy and product pipeline requirements.
- Oversee facility design for aseptic processing operations, including cleanroom classifications, contamination control strategy, filling systems, lyophilization, and sterile formulation
- Ensure design supportsqualification,regulatoryapprovaland operational excellence from day one.
- Manage capital expenditure including cost forecasting, change management, and financial reporting
- Establish a risk-basedCQV strategythatleveragesdigital technologies andenables accelerated timeline of facility and equipment qualification
- Identifyand mitigate technical, regulatory, schedule, and supply chain risks associated with large-scale pharmaceutical capital projectswithplansfor what-if scenarios
- Build and lead a high-performing project organization including program managers, engineering leads, construction managers, CQV leads, and projectcontrolsprofessionals.
- Foster a culture of safety, accountability, collaboration, and operational excellence.
Qualifications
- BS,Engineeringor equivalent technical degree;Masters degree in Engineeringor MBA preferred
- 20+ years of experience as a SeniorEngineering/Projects /Operations Leader across multiple technologies.
- Proven leadership experience delivering mega-capital projects ($500MM$1B+), preferably in biopharmaceuticals.
- In-depth technical and operationalexpertisewith aseptic drug product manufacturingoperations and facilities
- Proven inclusive management and leadership capabilities of largecross-functional teamsand the ability to effectively interact and communicate with seniorleadershipand executives from strategic partners andauthorities
- Demonstrated experience managing Engineering, EPC/EPCM contractors and global equipment vendors
- Results-oriented leadershipwith outstanding negotiation skills andrisk-baseddecision making isrequired
- Ability to mentor and develop next generation of leaders
- Travel within the USoutside the US forreviews/workshops/visits to vendor facilitieswill berequired
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible toparticipatein our long-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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