Principal Project Manager

As part of the New Products Initiatives organization, this position provides a unique opportunity to collaborate across the different functions within Project Management Office (PMO), Regulatory Affair, Research and Development (R&D) and with functional areas such as Operations, QA, Legal, Engineering, and Commercial. This individual will work closely with the Director of Capital Projects to execute Curium's strategic initiatives as well as Maintenance of Business (MOB) projects across the North American Operations team. This position requires effective communication on program status to senior leadership across the company.

This role reports to the Director of Capital Projects and will manage and support the capital needs of R&D/Operations strategic projects and initiatives as well as the site MOB programs. The Principal Project Manager of Capital Projects is responsible for both identifying, scoping, and implementation of the capital requirements for new product development opportunities, and MOB projects for Curium North America. Responsibilities include cost estimating, equipment layout, detailed design, contractor selection, and implementation of all capital projects. The Principal Project Manager will work closely with individual internal customers to ensure the capital portion of the NPD/MOB projects meets the overall project needs. The individual in this role will be a member of the NPI organization and interact with all levels of leaders across operations/R&D and cross functionally with the North American leadership team.

This role will be responsible for helping to manage the North American capital program and will ensure projects are executed and managed successfully.

Work Schedule: Monday - Friday 7:00am - 4:00pm. Hours might be adjusted.

• Closely interact with all Operations Leadership Team (OLT) members and their respective functions to establish the capital budget, set capital priorities, and execute on capital requirements.
• Work closely with Portfolio Management, R&D, PMO and site focus factory management to provide support for all capital initiatives defined by the Curium leadership team.
• Work with the PMO group during concept phase to provide scoping, scheduling, and cost information for capital requirements for new products.
• Work with the Engineering department to ensure capital purchases meet the site requirements.
• Work closely with the Engineering department to keep site equipment standards current.
• Coordinate with maintenance team and outside contracting team supporting New Product Development, and Maintenance of Business.
• Conduct field inspections during implementation and installation of capital equipment for all New Product Development and Maintenance of Business projects. A minimum of 10% of the time should be spent on field review.
• Coordinate and organize (agenda, minutes, tracking, planning) meetings and provide input for site specific meetings such as Town hall meetings and the site monthly report out meetings.
• Develop Capital Appropriation Requests (CAR) for NPD/MOB projects.
• Maintain up-to-date knowledge on engineering standards and construction practices.
• Through Project Management systems, capture and share information from each project to drive continuous improvement and best practices.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor Degree in Engineering required.
• 8 or more years of relevant work experience in capital project management required. Preferred experience with Pharmaceutical capital project needs.
• Technical understanding of the pharmaceutical development process from concept to launch; preferably in finished dosage products.
• Knowledge / experience in aseptic / terminally sterile operations; isolator technology, tech transfer and scale up techniques with experience in manufacturing operations preferred.
• Team member and Team Leader experience, strong evidence and mastery of being a Team contributor.
• Experience managing a group of pharmaceutical professionals and engineers.
• Demonstrates strong interpersonal skills, including ability to maintain composure and professionalism under pressure.
• Allocate resources effectively across multiple projects and appropriately set priorities.
• Work well under tight and conflicting deadlines.
• Excellent written and oral communication skills.
• Strong interpersonal and negotiation skills, conflict management, priority setting, strategic agility, building effective teams, managing vision and purpose.
• Strong management, time-management, and organizational skills.
• Proficiency in computer skills and experience with Microsoft Word, PowerPoint, Excel, and experience with Project Management software.
• This position may require limited travel.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.