Project Manager

Project Manager, Contractor

This role is 100% Onsite in Devens, MA

Work Schedule is Mon – Fri, Business Hours

The Devens Biologics Manufacturing Project Management Office (PMO) Project Manager will manage and/or support the aspects of initiating, planning, and executing complex, multi-disciplinary projects throughout the projects’ lifecycle. With a breadth of hands-on project management experience in the Pharma/Biotech regulated environments, the Project Manager (PM) is expected to manage critical Biologics PMO projects in support of specific site and product programs. The PM will work with for the Devens Biologics Associate Director of PMO & Business Operations and with the PMO and the Operational Excellence (OpEx) team members to ensure alignment and coordination across site priorities. The PM will be responsible for using Devens PMO best practices, tools & templates and will be proficient in PMI project management standards, processes, procedures, and guidelines. The successful candidate must have a proven record of extensive professional experience and the drive to steer internal partners to efficient delivery of the projects on time & within budget.

Primary Responsibilities:

• Apply project management expertise across the portfolio for both standard and complex projects, managing multiple projects in parallel.

• Define project scope / goals / deliverables / budget / timeline

• Develops Work Breakdown Structures (WBS) and project plans with project team & Project Lead. Manages WBS in a Project Portfolio Management system (iPlan) and/or MS-Project. Sequences WBS activities, facilities discussion with project team to estimate activity resources and durations.

• Facilitates resource planning for project teams throughout the lifecycle of a project.

• Create project plans and manage dependencies, milestones, and deliverables

• Manages project schedules, including reconciling completed/not completed activities and proactively communicates upcoming activities to project team members.

• Aligns with Project Lead and Sponsor to take action(s) to drive performance of cross-functional teams. Appropriately escalates concerns to Project Lead or recommend escalation to project Sponsor.

• Partners with Project Lead to ensure successful delivery of projects. Schedules meetings for project team,

prepares meeting materials with/for lead as requested, facilitates team meetings as needed, and documents actions & decisions during project team meetings.

• Identify, handle, and resolve project-related issues and risks by developing specific action / risk mitigation / contingency plans and escalating early to Associate Director of PMO & Business Operations when necessary

• Prepare and present the business cases and communicate status for the assigned projects to the Leadership Team and/or Steering Committee(s). Clearly and concisely frames discussion topics to senior leaders to drive decisions

• Monitor execution and quality to customer / stakeholder / sponsor standards

• Independently leads large cross-functional project(s).

• Evaluate and assess the project outcome

Competencies & Experiences:

• 4 – 7 years of experience project management in a GxP environment

• 4 – 7 years of experience in Biologics / Pharmaceuticals with strong knowledge of biopharma industry

• Understanding of GMP and FDA regulatory requirements correlating to biologics

• Advanced degree in Life Sciences or technical field

• Project Management Professional (PMP) certification preferred

• Proficiency with related software tools such as: iPlan, MS Project, OneNote, MS PPT, MS Excel, etc.

• Experience with SharePoint, Smart Sheets, ServiceNow, etc.

• Solid analytical skills, problem solving and financial acumen

• Exceptional communication skills including ability to take an independent stance when interfacing with cross-functional stakeholders.

• Demonstrated focus on being able to translate data and metrics into predictable, value-add business insight

• Comfortable with uncertainty and meeting tight deadlines in the matrix environment.

• Demonstrated high degree of independence, requiring minimal supervision from senior management.

• Highly motivated, highly organized, passionate self-starter: detail-oriented and operationally focused

Physical Demands:

• This position is an office-based position that may require entry into laboratory/manufacturing spaces that requires appropriate levels of personal protective equipment (PPE).

• Office-based work requires sitting and repetitive use of arms/hands/wrists, especially when working with a computer.

Ivory Systems