Alliance Project Manager

Work Location: Wake County, NC

Summary:

The Alliance Project Manager plays a pivotal role in bridging client needs with scientific execution, overseeing complex pharmaceutical projects from development through commercial manufacturing. This position requires strong organizational, technical, and leadership skills to drive collaborative product development, process improvements, and regulatory compliance. The role involves close coordination with internal teams and external partners to ensure successful project outcomes and client satisfaction.

Responsibilities:

• Oversee the full project life cycle, managing pharmaceutical projects from early development through clinical and commercial production.
• Act as process owner, proactively planning and leading activities to ensure robust product and manufacturing processes align with development timelines.
• Serve as a technical expert in formulation, analytical development, manufacturing processes, and stability studies, representing process-related issues internally and externally.
• Review project deliverables, provide technical and scientific support, and contribute to remediation initiatives and reporting.
• Lead technology transfer activities, ensuring seamless process transitions between sites and manufacturing facilities.
• Identify and mitigate technical and logistical risks, implementing corrective actions and solving problems as they arise.
• Coordinate cross-functionally with R&D, QA, Analytical Services, Supply Chain, and Manufacturing teams to resolve process development and manufacturing issues.
• Act as the primary client contact, ensuring clear communication, client satisfaction, and driving continuous improvement initiatives in manufacturing processes and operational workflows.

Qualifications:

• Demonstrated leadership in project management, with experience leading complex projects and cross-functional teams.
• Proven ability to manage internal and external stakeholders in formulation, process, and analytical development environments.
• High proficiency with project management software tools (e.g., Smartsheet, SharePoint) for project and execution management.
• Strong technical background in manufacturing operations, particularly with protein formulations, development, and manufacturing.
• Experience supporting process development and technology transfers from R&D or pilot-scale to clinical production, including risk assessment and mitigation strategies.
• Comprehensive knowledge of GMP and regulatory requirements, including cGMP manufacturing regulations for aseptic fill/finish products and associated validation/qualification standards.
• Excellent oral and written communication skills.
• MS with at least 8 years or BS with at least 10 years of industry experience in a relevant physical or biological scientific field (such as biochemistry, chemical engineering, or bioengineering).
• Ability to supervise team members as needed, depending on organizational requirements.

Published Category: Project Management