CMC Project Manager: Pharma Development & Regulatory

Stira Pharmaceuticals LLC; Fairfield (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Stira Pharmaceuticals LLC, a sterile injectable CDMO, seeks an experienced Project Manager to lead CMC activities, manage development, manufacturing, and regulatory submissions to ensure timely delivery of quality products.

The role requires coordinating cross-functional teams across R&D, Manufacturing, Regulatory Affairs and Quality Assurance, with strong project management, regulatory knowledge, and excellent communication to advance innovative therapies.

Qualifications

• Proven ability to lead CMC projects and teams.
• Solid understanding of drug development and CMC regulatory requirements.
• Experience coordinating with R&D, Manufacturing, Regulatory Affairs and QA.

Responsibilities

• Lead planning, execution, and completion of CMC projects to meet timelines and quality standards.
• Collaborate with internal and external stakeholders to achieve CMC milestones.
• Develop and maintain detailed project plans including resources, risks, and budgets.
• Monitor project performance, identify risks, and implement corrective actions.
• Serve as primary CMC communications contact for internal teams and external partners.
• Oversee preparation and submission of CMC documentation to regulators.
• Align CMC activities with overall project goals and regulatory strategies.
• Provide status updates to senior management on risks and opportunities.
• Foster a collaborative, high-performing CMC project team.

Skills

Project management

Cross-functional teamwork

Regulatory knowledge

Communication

Education

Bachelor's degree in Chemistry / Chemical Engineering / Pharmaceutical Sciences

PMP certification

Job description

Stira Pharmaceuticals LLC, a sterile injectable CDMO, seeks an experienced Project Manager to lead CMC activities, manage development, manufacturing, and regulatory submissions to ensure timely delivery of quality products.

The role requires coordinating cross-functional teams across R&D, Manufacturing, Regulatory Affairs and Quality Assurance, with strong project management, regulatory knowledge, and excellent communication to advance innovative therapies.