at J&J Family of Companies in Dover, Delaware, United States
Director, Project Management- Drug Substance Manufacturing – ******** W
Description Johnson & Johnson is recruiting for a Director, Project Management- Drug Substance Manufacturing. This position to be located in USA east coast.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are more thoughtful and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
At Engineering & Property Services (E&PS) we take care of all J&J buildings around the world providing end to end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management. We have a profound influence on the entire J&J Enterprise, providing innovative workplaces where our employees can collaborate and grow, and delivering flexible site solutions which enable our business to best serve our customers and patients.
The Director, Project Management Drug Substance Large Molecule is accountable for the construction and delivery of a Large Molecule Drug Substance facility. Leading through Flawless Project Execution, the oversight and flexible application of scalable Project Delivery Processes required and leading thru the Ideation, Definition, Execution and Assessment phases; including, but not limited to driving innovation to ensure safety and appropriate construction quality, reducing cost and schedule, leading on learning adoption internally and externally, overseeing commissioning, qualification activities and supporting operational readiness, technology transfer, process and product validation and regulatory approval.
This role is responsible for managing and ensuring the project progress leading the expedition of key activities across function, find solutions to key problems, and communicate project progress, issues and solutions to management and to the project team, and also training and mentoring Project Managers (internal and external) to develop leadership skills and capabilities in project ideation and delivery.
A suitable candidate for this role must have excellent end-to-end leadership experience on all aspects of Project Management including ideation and business value realization of complex " MEGA " capital projects ($250MM ). The candidate shall also have proven experience and knowledge for the Design, Construction, C&Q and Startup of Pharmaceutical Large Molecule Drug Substance manufacturing.
Key relationships include collaboration with Engineering & Property Services (E&PS) functions (Real Estate, E&D, PD and FM), Procurement, Environmental Health & Safety, Information Technology and J&J Innovative Medicines engineering groups among other functional areas, establishing highly collaborative working relationships with key partners and business leaders.
Key Responsibilities: + Leads and directs projects through Ideation, Definition, Execution and Assessment phases of large capital projects.
+ Leads the selection of appropriate project functions and project resourcing.
+ Leads the development of strategies for Project Delivery via Project Execution Plan based on the complexity of the project ensuring consistency with business strategy, applicable policies, commitments, and goals.
+ Leads teamwork of the Engineering Groups across other functional areas, establishing effective working relationships with all Business Partners.
+ Leads the Alignment of the Sponsor, Key Partners, Core and Extended team to define and align on the Final Project Objectives.
+ Leads the development and reporting of Key Performance Indicators and ensures they are met by developing and executing the proper action plans.
+ Leads communication via E&PS Project SPOC to Sponsors to Key Partners on all aspects of projects and maintains strong internal project communications.
+ Leads the coordination of the design, execution and close out of all projects related activities including managing internal resources and the procurement of third-party contractors, suppliers and consultants and ensures the project remains on plan to deliver Final Project Objectives.
+ Responsible for safety, scope management, contract and construction management, legal and corporate compliance, quality, project controls, commissioning, and qualification.
+ Leads Risk Management, evaluates, eliminates, or mitigates risks to Final Project Objectives, including resource issues, conflicts, and other obstacles, negotiating with Sponsors, Functional Managers, Core and Extended Team members for appropriate resources.
+ Leads the process of change identification and requests for changes, liaising with and informing the Sponsor, Core and Extended teams.
+ Support Operational Readiness, Process Validation and Technology Transfer activities up to approval by the applicable regulatory agencies (ie. FDA ).
+ Leads Project Close Out activities including operational handover and financials.
+ Ensure lessons learned are accurately documented and provide feedback to ensure continuous improvement via lessons collection and lessons adoption.
Qualifications Education: + Bachelor's degree in engineering, Architecture or Construction Management is required. Master's Degree is preferred.
Experience and Skills Required: + Minimum of 10 years of relative business experience and project and operations management.
+ Prior experience managing complex capital projects (larger than $250MM), specifically in the Large Molecule Drug Substance Pharmaceutical industry, including Upstream and Downstream Processing, Clean Utilities, Process Automation, Cleaning ( CIP ), Sterilization ( SIP ) and other required support systems.
+ Technical knowledge and experience of understanding and translating complex business needs into engineering concepts.
+ Highly skilled in leading and motivating remote and virtual teams and partners.
+ Track record of developing and maintaining highly collaborative partnerships at all levels within the organization including Internal (Real Estate, Engineering, and Facilities Management) and external (Procurement, Process Engineering, Finance and Operations).
+ Full working understanding of Project Controls, specifically in cost and integrated schedule development, financial assessments and detailed control of cost and schedule.
+ Manufacturing experience in FDA or other regulated environments from design through commercial startup.
+ Detailed knowledge of contracting and a skilled negotiator.
Preferred: + LEED AP certification
+ Knowledge of Project Delivery principles and processes.
Other: + Project Management Professional ( PMP ) or equivalent is required.
+ Proficient in Microsoft applications (ie. Outlook, Word, Excel, Microsoft Project, and PowerPoint).
+ This position may require up to 25% of domestic and/or international travel.
The anticipated base pay range for this position is $142,000 to $244,950.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, s
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