Summary

As a Capital Project Manager in the life science industry, specifically focusing on pharmaceuticals and cell & gene therapy, you will be responsible for leading and managing capital projects from initiation to completion. With 4-8 years of experience, you will have a strong background in project management, engineering principles, and industry-specific regulations. You will collaborate with the client and cross-functional teams to deliver successful projects, ensuring adherence to quality, safety, and compliance standards. This role requires exceptional client relations, leadership, communication, and problem-solving skills to drive project success in the dynamic and fast-paced field of life sciences.

Job Functions, Essential Duties & Responsibilities

Project Planning and Strategy:

• Collaborate with stakeholders to define project scope, goals, and objectives.
• Develop detailed project plans, including timelines, budgets, and resource allocation.
• Create strategies to effectively manage risks, changes, and potential roadblocks.
• Ensure alignment of project objectives with organizational goals and regulatory requirements.

Project Execution and Management:

• Lead project teams through all project phases, including design, procurement, construction, commissioning, and validation.
• Monitor project progress, identify potential issues, and proactively implement mitigation strategies.
• Ensure adherence to quality, safety, and compliance standards, including FDA, cGMP, and industry-specific guidelines.
• Manage project budgets, tracking expenses, and ensuring financial objectives are met.

 Stakeholder Engagement:

• Foster effective communication and collaboration among project team members, contractors, vendors, and internal stakeholders.
• Serve as the primary point of contact for project-related communications, updates, and issue resolution.
• Conduct regular meetings to provide status updates, address concerns, and facilitate decision-making.
• Manage expectations and ensure alignment between project goals and stakeholder requirements.

Job Functions, Essential Duties & Responsibilities 

Resource Management:

• Identify and allocate resources needed for project execution, including personnel, equipment, and materials.
• Monitor resource utilization and adjust as necessary to meet project objectives efficiently.

 Risk Management and Problem-Solving:

• Identify potential risks and develop risk management plans to minimize their impact.
• Implement problem-solving strategies to address project issues and obstacles.
• Analyze project data and performance metrics to drive continuous improvement.
• Encourage a culture of innovation and creative problem-solving within the project team.

 Documentation and Reporting:

• Ensure accurate and timely documentation of project activities, milestones, and deliverables.
• Generate comprehensive project reports, highlighting progress, key metrics, and deviations from planned objectives.
• Maintain project documentation, including change control, technical specifications, and regulatory compliance records.

Qualifications, Education and/or Experience

• Bachelor's degree in engineering, project management, or a related field. Advanced degrees are a plus.
• Minimum of 8 years of experience in capital project management within the life science industry, with a focus on pharmaceuticals and/or cell & gene therapy.

Skill Sets, Core Competencies

• Exceptional ability to build and maintain client relationships and trust.
• Excellent organizational, communication, and leadership skills.
• Ability to work effectively with cross-functional teams and stakeholders at various levels.
• Proficiency in project management tools and software.
• Exceptional problem-solving and decision-making abilities.
• Attention to detail and ability to manage multiple priorities simultaneously.
• Working knowledge of related industries manufacturing operations, product and process development, and supply chain operations in a cGMP-regulated environment.
• Results oriented approach to departmental performance.
• Ability to build relationships and influence and motivate others
• Adaptable to managing change.
• Working knowledge of regulatory compliance issues in regulated manufacturing.
• Thorough understanding of engineering principles and project life cycle in the life science industry.
• Proven track record of successfully managing complex projects on time and within budget.
• Capable of handling multiple tasks/projects.
• Ability to navigate and thrive in a fast-paced, dynamic work environment.

Certificates, Licenses, Registrations

• Project Management Professional certification is preferred

Work Environment, Physical Demands

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.