Summary of PositionThe Senior Project Manager role provides a unique opportunity to collaborate across the different functions including Regulatory Affairs, Research and Development (R&D), Operations, Quality, Supply Chain, Finance, Legal, HR, Engineering, Marketing and Commercial. This individual will work closely with the Senior Director of Program Management and the Principal Project Manager Maintenance of Business (MOB) projects to implement Curium's strategic initiatives as well as MOB projects across the North American Operations team. This position requires effective communication on program status to senior leadership across the company.
Work Schedule: M- F 8am 5pm
Essential Functions - Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Coordinate and align multiple shared services (i.e., QC, Validation, Operations) activities between board approved New Product Development (NPD)and MOB-related initiatives.
- Provide Project Management Services for North America Strategic Business Initiative projects that are classified as NPD or MOB.
- Improve integrated risk management across NPD, MOB and Strategic Business projects.
- Coordinate MOB and Strategic Business Initiatives to be integrated, where necessary, in escalation and governance process where critical projects are managed and reported.
- Lead efforts in improving and enhancing the PMO process/governance structure and systems initiatives. Areas of focus could include resource management across all functional groups for NPD, MOB, and other Strategic Business issues; optimizing the financial forecasting process; supporting PMO portfolio software implementations; Assisting with execution of stage gate process for all projects.
- Provide PM Services, when necessary, to ensure business continuity within the PMO.
- Present project status/issues/risks to the Project Review Committee team members and provide recommendations on project direction.
- Work with the PMO group during concept phase to provide scoping, scheduling, and cost information for requirements.
- Provide PM services/support for elements of Integration activities for M&A.
- Through Project Management systems, capture and share information from each project to drive continuous improvement and best practices.
- All other responsibilities as assigned with or without accommodation.
Requirements - Bachelor lever degree in engineering or related sciences or equivalent experience.
- 5+ years of experience in pharmaceutical industry and leading cross-functional projects
- Technical understanding of the pharmaceutical processing
- Knowledge/experience in aseptic/terminally sterile operations; isolator technology a plus
- Knowledge/experience in radiopharmaceutical industry and operations a plus
- Experience in manufacturing operations preferred
- Team member and Team Leader experience.
- Strong evidence and mastery of being a Team contributor.
- 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.
- PMP certification preferred.
- Strong in computer skills and experience with Microsoft Word, PowerPoint, Excel, Visio, MS Project and experience with Project Management software.
- Experience in ERP/data base management a plus.
- Lean or Six Sigma trained/certified a plus.
- 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.
Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Job Segment: Project Manager, Compliance, R&D Engineer, Supply Chain Manager, Nuclear Engineering, Technology, Legal, Engineering, Operations
