Associate Director of Project Management

We are seeking a strategic and results-driven Associate Director of Project Management to lead complex, cross-functional programs supporting the commercialization and lifecycle management of sterile injectable products. This leadership role sits at the intersection of technical operations and commercial supply chain, ensuring seamless execution from manufacturing through global distribution.

You will play a critical role in driving supply reliability, accelerating product launches, and optimizing end-to-end supply chain performance in a highly regulated environment.

Key Responsibilities

Strategic Leadership

• Lead and mentor a team of project managers supporting sterile injectable programs
• Drive portfolio governance, prioritization, and resource allocation across multiple projects
• Partner with senior leadership to align project execution with business and commercial strategy
• Organized, proactive, and thrive in a dynamic, fast-paced, timeline-based environment.

End-to-End Project Oversight

• Oversee project execution from late-stage development through commercial supply and post-launch lifecycle
• Ensure delivery of projects on time, within scope, and within budget
• Establish and maintain robust project management frameworks, tools, and KPIs

Commercial Supply Chain Integration

• Lead coordination across manufacturing, packaging, logistics, and distribution networks
• Ensure uninterrupted commercial supply through proactive risk identification and mitigation
• Optimize inventory strategies, production planning, and distribution flows

Technical & Operational Excellence

• Experience with technology transfers from development to commercial manufacturing
• Provide oversight of sterile manufacturing operations, including aseptic processing and fill-finish activities
• Ensure alignment with cGMP, regulatory requirements, and quality standards
• Drive resolution of complex manufacturing and supply chain challenges

External Partner & Stakeholder Management

• Manage relationships with CMOs/CDMOs, suppliers, and logistics partners
• Serve as executive point of contact for key stakeholders
• Lead governance meetings and provide executive-level reporting

Regulatory & Compliance

• Ensure alignment with regulatory filings and post-approval commitments
• Champion quality and compliance culture across all projects

Qualifications

Education

• Bachelor’s degree in Pharmacy, Engineering, Life Sciences, or related field
• MBA or advanced degree preferred
• PMP or equivalent certification strongly preferred

Experience

• 10 years of progressive experience in pharmaceutical/biotech operations, manufacturing, supply chain, or project/program management, including 5 years in leadership roles.
• Significant experience with sterile injectables (aseptic manufacturing, fill-finish, lyophilization)
• Proven leadership experience managing teams and complex project portfolios
• Deep expertise in commercial supply chain operations and global distribution
• Strong experience working with CMOs/CDMOs
• Understanding of CMC development lifecycle, regulatory submission processes, and post-approval change management
• Experience with combination product/medical device post-approval projects
• Proficiency with project management tools (e.g., MS Project, Excel, PowerPoint, SharePoint)

Core Competencies

• Strategic thinking and executive leadership
• Advanced project and portfolio management
• Deep understanding of GMP and regulatory requirements
• Strong business acumen and supply chain expertise
• Excellent communication and stakeholder influence skills
• Risk management and decision-making under uncertainty

Additional Information

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $110,000-$130,000.

You’ll have the option to work remotely.