Validation - Project Manager

Location: Summit, NJ

Work Arrangement: 100% onsite

Duration: 12 Months Contract

Must Haves:

• Must be competent in Project Management tools and methodologies such as Microsoft Project.
• Excellent organizational and time management skills.
• Experience within a regulated GMP environment for manufacturing (Biologics or Cell Therapy experience is a plus).
• Strong analytical, problem-solving, and critical thinking skills.

Purpose and Scope of Position:

The Project Manager will develop project plans, manage timelines, and identify and respond to critical path barriers. This role requires significant collaboration across internal and external functions to ensure the on-time release of the final product. The ideal candidate will have demonstrated ability to balance multiple competing priorities and manage projects.

The role requires working in a cross-functional and dynamic setting where project assumptions and scenarios may change. Therefore, it requires an individual who can quickly adapt to changes and manage communications at different levels within the organization.

The work scope includes operations excellence, continuous improvement projects, and capacity expansion projects supporting commercial products. This role collaborates with project management and subject matter experts across multiple sites, including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, PMO, IT, EHS, Finance, Regulatory, and Clinical and Commercial Operations.

Required Competencies:

Knowledge, Skills, and Abilities:

• Ability to work independently.
• Ability to matrix manage cross-functional teams.
• Must be competent in Project Management tools and methodologies.
• Excellent organizational and time management skills.
• Experience with regulated GMP environments for manufacturing (Biologics or Cell Therapy experience is a plus).
• Strong analytical, problem-solving, and critical thinking skills.
• High attention to detail.
• High organizational skills with the ability to manage multiple objectives in parallel.
• People and project management skills.
• Advanced proficiency in MS Office applications.
• Proficient written and verbal communication skills.
• Ability to develop and provide training on various functions.

Education and Experience:

• Bachelor’s degree required in Science or Engineering.
• 5+ years of relevant work experience, preferably in a regulated pharmaceutical manufacturing environment.
• PMP certification strongly preferred.
• Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization.

Duties and Responsibilities:

• Manage multiple low to medium complexity process improvement and/or technical projects and timelines.
• Effectively manage team meetings, including scheduling, preparing agendas, developing meeting minutes, and following up on action items.
• Serve as a member of sub-teams, tracking timeline elements to ensure functional deliverables are completed on time and meet quality standards.
• Develop critical path analyses with the team to identify risks and opportunities within project timelines and help develop contingency plans.
• Prepare routine status reports and communicate project progress to stakeholders.
• Lead operational projects, including weekly QC LIMS huddles, QC CTDO LIMS planning and management, and monitoring tools.
• Ensure team recommendations related to project direction and timelines needing governance endorsement are reviewed at appropriate milestones.
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
• Develop and implement KPI and reporting capabilities.
• Collaborate with IT Business Partners to support modeling, scheduling simulation implementations, and automated scheduling tools.