Senior CMC Project Lead, Biologics Manufacturing

Uniquity Bio Inc.; Malvern (Chester County); On-site; USD 180,000 - 230,000; Full time

Job summary

Uniquity Bio is seeking an Associate Director of Manufacturing Development and Operations Project Management in Malvern, PA. You will lead cross-functional CMC programs for monoclonal antibodies from early development through commercialization, coordinating internal teams and external partners to deliver on time and within budget.

The role demands strong leadership, risk management, and clear communication to ensure regulatory readiness, tech transfer, process development, and analytics align

Qualifications

• 8–12+ years in biotechnology/pharmaceutical development with at least 5 years in CMC/Technical Operations project management.
• Strong understanding of biologics CMC development and monoclonal antibody programs.
• Experience with GMP manufacturing, process development, tech transfer, analytics, release testing, and regulatory CMC activities.

Responsibilities

• Lead cross-functional CMC project management activities for monoclonal antibody development programs from preclinical development through commercialization.
• Coordinate manufacturing activities across drug substance and drug product development, including process development, technology transfer, GMP manufacturing, and stability programs.
• Develop, maintain, and communicate detailed project timelines and milestones using PM tools.
• Monitor project progress with KPIs, manage risks, and drive mitigation strategies.
• Lead cross-functional team meetings, provide status updates, and escalate risks when needed.

Skills

Project leadership

Cross-functional collaboration

Leadership

Communication

Risk management

Problem-solving

Budget awareness

Education

Bachelor's degree in Engineering, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related

Advanced degree preferred

Tools

Microsoft Project

Smartsheet

Microsoft Office

Job description

Uniquity Bio is seeking an Associate Director of Manufacturing Development and Operations Project Management in Malvern, PA. You will lead cross-functional CMC programs for monoclonal antibodies from early development through commercialization, coordinating internal teams and external partners to deliver on time and within budget.

The role demands strong leadership, risk management, and clear communication to ensure regulatory readiness, tech transfer, process development, and analytics align