Director of Supply Chain (Planning, Label, Pack and Launch)

Key Responsibilities:

In this position, you will lead the development and execution of supply chain strategies to support both clinical-stage and future commercial programs.

• Design and oversee the supply chain framework to align with broader business objectives across clinical and commercial phases.
• Manage the design, development, and qualification of labeling and packaging solutions for both clinical trials and commercial distribution.
• Oversee the selection and onboarding of contract manufacturing organizations (CMOs) for labeling and packaging services.
• Build and maintain strong vendor relationships to ensure consistent supply, quality, and cost control, while mitigating potential disruptions.
• Implement artwork and serialization systems to maintain regulatory compliance and product traceability.
• Lead planning and forecasting activities to ensure on-time availability of clinical and commercial materials.
• Conduct shipping validation studies in support of regulatory submissions.
• Coordinate with third-party logistics providers to manage inventory and facilitate timely delivery to clinical sites.
• Promote continuous process improvement to drive efficiency, compliance, and cost savings.
• Contribute to the long-term objective of achieving a successful product launch.

Qualifications:

• Bachelor's degree in Engineering or a related discipline, with 7-10 years of experience in a highly regulated industry (e.g., cGMP).
• Experience in the design and execution of commercial packaging strategies for biologic products.
• Prior experience managing external manufacturing partners for packaging and labeling, including familiarity with DSCSA compliance.
• Preferred: experience supporting regulatory filings such as INDs and BLAs.
• Strong problem-solving skills and a collaborative mindset with a hands-on approach to complex challenges.
• Excellent communication skills and the ability to thrive in a cross-functional, team-oriented environment.