Project Coordinator

• Hybrid- Minimum 50% onsite required and may change based on business needs
• Bachelor's degree required.
• Ability to prioritize critical project timelines.
• Experience in tools such as project/s. MS Project, Smartsheet, Jira-like software.
• 6 Sigma, PMP certifications are preferred.

• The Project Management Specialist of CPV & CI, within the MSAT organization, will support the project timelines, to support the Summit, NJ Cell Therapy facility.
• The Project Specialist, provides project management support ensuring projects are executed within established quality metrics, budgets and timelines.
• This includes planning, developing, implementing and evaluating projects, coordinating project activities, collaborating with project team members, developing measurable project goals and objectives and monitoring progress toward achievement.
• This also includes supporting the development of project management and continuous improvement competencies.
• The Project Specialist participates in project development, disseminates project information and is an active participant in project execution.
• The organization being supported is a 24x7x365 manufacturing facility, located in Summit, NJ.
• Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12.
• This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, SBO (Strategic Business Operations) and the broader MSAT organization.
• Execute project activities.

• Organize and conduct project team meetings and facilitate discussions.
• Participate in department and site project teams.
• Generate project documentation (e.g. schedules, status reports) and manage activities according to site objectives and timelines.
• Demonstrate basic understanding of site quality GxP systems supporting document management, change controls.
• Participate in planning project related implementation tasks.
• Interact and collaborate with internal departments, as well as external stakeholders as needed.

• Execute departmental activities.

• Support development of project management and continuous improvement competencies, perform training.
• Support department staff by:
• Tracking performance against plan for project activities and deliverables.
• Compiling project related information, preparing budget proposals and reports in a timely manner.
• Documenting project risk identification and mitigation plans.
• Update project status weekly through the Tier board and iPLAN project dashboards.

• Performs other tasks as assigned.

• The incumbent will be required to adhere to the current Client policies and procedures.
• The incumbent will be required to sit at a desk and type/view a monitor for extended periods of time.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
• There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
• Employees holding this position will be required to perform any other job-related duties as requested by management.

• Reports to Associate Director, Manufacturing Science & Technology (MSAT), Cell Therapy

• Project management experience using proven methods/tools.
• Ability to utilize tools like MS project and Smartsheet is a must.
• Excellent prioritization skills
• Able to partner with other groups and make meaningful connections. Being able to negotiate and proactively remediate and prioritize.
• Basic knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations
• Must be detail oriented and able to oversee/manage multiple projects, with a proven track record of impeccable time management, to meet timelines.
• Possess strong verbal/written communication skills to enable working with internal/external parties and/or leading cross-functional teams.
• Intermediate knowledge of evaluating data using statistics and statistical tools, to make data driven decisions.
• Ability to think strategically and to translate strategy into actions.

• Bachelor's degree required, preferably in Science or Engineering.
• 4 years' relevant work experience required, preferably in a regulated pharmaceutical environment.
• Experience within a PMO (Project Management Organization) and/or PM (Project Management) preferred.
• An equivalent combination of education, experience and training may substitute.
• Experience with Operational Excellence and Lean Manufacturing is a plus.

• None

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