Summary of PositionThe Project Manager will work in a dynamic organization in the Project Management Office (PMO) for North America. This role has the responsibility for supporting and implementing projects related to Curium's business strategy. Although this role largely supports new products, the Project Manager may support or execute projects in other PMO spaces such as capital and maintenance of business projects. Projects can include technical transfer, drug development, scoping, integration, etc.
Work Schedule: Monday - Friday 8am - 5pm
Essential Functions - 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.).
- Support and/or lead large cross-functional projects, project teams and strategic efforts.
- Perform detailed risk and financial data analysis to identify and present the best project portfolio alternatives to the executive committee.
- Utilize project management tools, software and integration best practices to quickly move projects from scoping to implementation.
- Provide and maintain forecast estimates for project related costs and general project task tracking for adherence to project milestone goals.
- Maintain complete cross-functional responsibility for facilitating and managing completion of all required elements of the project strategy including Marketing, Manufacturing, Quality, Logistics, Product Monitoring, Legal, Finance, Clinical and Regulatory
- Develop the project Risk Management Plan including upsides, contingencies, and mitigations.
- Monitor and communicate project status through governance mechanisms, ensuring appropriate escalation and remediation, and the sustainment of developing processes and systems.
Requirements - Bachelor Degree in Chemistry, Engineering or related field; coursework or certification in project management
- Minimum of 3 years of experience in project management with at least 3 years in a drug development role.
- Experience in pharmaceuticals desired but willing to consider other development areas such as medical device experience.
- Strong project management and organizational skills, including ability to work independently and as a team member.
- Familiar with project management tools and best practices
- Proven ability in setting priorities and organizing work to meet deadlines.
- Technical understanding of the pharmaceutical development process from concept to launch.
- Proven experience in leading complex multi-discipline project teams in a highly regulated environment
- Impeccable attention to detail
- Strong oral and written communication skills with proven ability to communicate effectively in high pressure environments.
- Ability to react to problems and lead the team to develop solutions while communicating effectively to the executive team.
- Proven track record of developing accurate project budgets and schedules.
- Ability to maintain collaboration in a result driven environment
- Agile approach and willingness to learn new things ability to work "on the fly" in a dynamic setting.
- Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio
- Travel may be required up to 25% of the time.
- Experience managing projects with Project and Portfolio Management software.
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, Pharmaceutical, Compliance, Medical Device, Marketing Manager, Technology, Science, Legal, Healthcare, Marketing
