Associate Director, CMC Project Managment

Uniquity Bio is a biopharmaceutical organization that develops high-potential medicines through scientific excellence, operational discipline, and adaptable development approaches. The Associate Director, CMC Project Management will lead CMC projects across the product development lifecycle, coordinating timelines, resources, risks, budgets, and cross-functional communication while supporting regulatory, quality, development, and commercialization activities.

Responsibilities:

• Leading Chemistry, Manufacturing, and Controls (CMC) projects across the product development lifecycle
• Oversees planning and execution of CMC activities, including timeline management, risk assessment, resource coordination, and cross-functional communication with internal teams and external partners
• Drive project plans for drug substance and drug product, ensure alignment with regulatory and quality requirements, and track progress against key milestones and budgets
• Organizing and facilitating CMC team meetings, maintaining project documentation, preparing status reports for leadership, and identifying and implementing process improvements to enhance efficiency and quality
• Partnering closely with technical, quality, regulatory, and supply chain colleagues to support successful development and commercialization of Uniquity Bio’s pipeline assets

Requirements:

• Candidates should possess strong Program Management and Project Management skills to lead complex CMC initiatives and coordinate cross-functional teams
• Candidates should possess Budgeting and financial tracking skills to manage project costs, forecasts, and resource allocations
• Candidates should possess Team Leadership skills, with the ability to influence without direct authority, foster collaboration, and drive accountability
• Candidates should possess Process Improvement skills to optimize CMC workflows, implement best practices, and enhance operational efficiency
• Advanced knowledge of CMC in biopharmaceutical development, including drug substance and drug product manufacturing, quality, and regulatory considerations
• Excellent written and verbal communication skills, including the ability to prepare clear project updates and present to senior leadership
• Strong organizational skills, attention to detail, and comfort working independently in a remote setting with global stakeholders
• Experience managing CMC projects in the pharmaceutical or biotech industry, preferably in small, agile organizations or matrix environments
• Bachelor's or Master's degree in a scientific or engineering discipline (e.g., Chemistry, Chemical Engineering, Pharmaceutical Sciences) or related field; PMP or similar certification is an advantage