Senior Manager, Project Manager - Biologics

Summary: The Senior Manager, Project Management will manage and/or support the aspects of initiating, planning, and executing complex, multi-disciplinary projects throughout Devens Biologics. With a breadth of hands-on project management experience in the Pharma/Biotech regulated environments, the Project Manager is expected to manage this critical initiative in support of specific site goals & objectives. The Project Manager will be responsible for using Devens PMO best practices, tools & templates and will be proficient in PMI program 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 program and projects on time & within budget.  This role will report to the Associate Director, Project Management Office (PMO) and Business Operations.

• Understand the business strategy and business process areas and ensure that these are best aligned.
• Identify appropriate technical solutions for business needs in partnership with the process owners and agreed suppliers, aligned to the Site Business Strategy.
• Partners with Devens Biologics Operations Leadership Team members and project sponsor(s) to ensure successful delivery of projects. Schedules governance / steering committee meetings for program team(s), prepares meeting materials with/for lead as requested, facilitates team meetings as needed, and documents actions & decisions during project team meetings.
• Apply project management expertise across the portfolio for project workstreams, managing multiple projects in parallel.
• Define project scope / goals / deliverables / budget / timeline.
• Develops Work Breakdown Structures (WBS), project plans and Agile Sprint planning with Project Sponsor, Workstream Leads & team members.
• Manages WBS in a Project Portfolio Management system (OnePlan) and/or MS-Project. Sequences WBS activities, facilities discussion with project team to estimate activity resources and durations.
• Facilitates resource planning for program teams throughout the lifecycle of the initiative.
• Develop critical path analyses to understand risks and opportunities within project timelines.
• Monitor project performance and progress, specifically to assure successful completion of short- and long-term goals.
• Identify potential risks in the program and conduct qualitative and quantitative risk analysis and develop & implement risk mitigation plans and strategies.
• Maintain program budgets and meet budgetary objectives by adjusting project constraints based on financial analysis.
• Create and communicate project plans and manage dependencies, milestones, and deliverables.
• Manages project schedules, including reconciling completed/not completed activities and proactively communicates upcoming activities to Steering Committee & Workstream Leads.
• Use Change Management methods to mitigate barriers to improvement efforts.
• Aligns with Associate Director of PMO to take action(s) to drive performance of cross-functional teams. Appropriately escalates concerns to Associate Director or recommend escalation to Site Leadership Team.
• Identify, handle, and resolve project-related issues and risks by developing specific action / risk mitigation /contingency plans and escalating early to Digital Transformation Program Leader 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.
• Serve as the primary point of contact for all project-related communications ​

Specific Knowledge, Skills & Abilities:

• Experience in leading Cross-Functional Projects and managing SME & technical professionals.
• Competence in Project Management methodologies such as Waterfall, Agile, Hybrid and Software Development Life Cycle (SDLC).
• Solid analytical skills, problem solving and financial acumen.
• Exceptional communication skills including ability to take an independent stance when interfacing with cross-functional stakeholders.
• Good facilitation, change management and interpersonal skills required. Expertise in conflict resolution.
• Demonstrated focus on being able to translate data and metrics into predictable, value-add business insight.
• Ability to translate business requirements into viable solutions.
• Knowledge of performance measurement tools and metrics.
• Comfortable with uncertainty and meeting tight deadlines in the matrix environment.
• Expertise in conflict resolution
• Demonstrate a high degree of independence, requiring minimal supervision from senior management.
• Highly motivated, highly organized, passionate self-starter: detail-oriented and operationally focused.
• Ability to understand project details but keep the overall “big picture” view of projects, priorities, and strategies.
• Successful experience working with cross-functional teams from Manufacturing, Quality, Site Engineering, MS&T, Digital Plant (IT), Finance, Operational Excellence, Biologics Development and Cell Therapy.

Education/Experience/ Licenses/Certifications:  

• Bachelor’s degree of Science/Engineering/Business required; Advanced degree is a plus.
• A minimum of 8 years program / project management in GxP Biopharmaceutical environment with strong experience with production and/or manufacturing operations, documented by a solid history of functional accomplishments and a proven track record.
• Understanding of GMP and FDA regulatory requirements correlating to biologics.
• Project Management Professional (PMP) certification is required.
• Agile / Scrum Master certification and Change Management Certification is a plus.
• Knowledge and previous work experience in Lean and Continuous Improvement.
• Excellent computer skills with proficiency in Microsoft applications- SharePoint, Project, PowerPoint, Access, Excel, Word, OneNote, Publisher.