CMC Project Manager

Job Title: CMC Project Manager

Duration: 8 months contract

Location: Foster City, CA 94404

Type of Position: Only on W2 basis

Foster City Hybrid role 3 days/week

FOCUS AREAS

• Lead integrated CMC planning across Drug Substance, Drug Product, Analytical, Quality, Regulatory, and Supply Chain, aligning deliverables, timelines, and priorities with clinical and regulatory objectives.
• Drive execution of CMC plans to ensure alignment with program milestones and overall development timelines.
• Provide end-to-end project management support across the product lifecycle, from development through commercialization and commercial manufacturing.
• Develop, maintain, and manage integrated project timelines in Planisware or Smartsheet, clearly defining dependencies, milestones, and critical path activities.
• Facilitate cross-functional Product Team meetings, including agenda development, decision documentation, and action item tracking.
• Proactively identify, assess, and manage program risks and issues; maintain risk registers and ensure timely mitigation and corrective actions.
• Coordinate preparation of high-quality governance materials in collaboration with Product Teams.
• Translate complex technical input from subject matter experts into clear, actionable insights to support strategic decision-making.
• Ensure clear, timely communication of program status and key updates to all stakeholders.
• Partner with Product Teams and Finance on budget planning, tracking, and forecasting.
• Ensure compliance with established processes and practices; identify and share best practices across Product Teams and PMs.
• Integrating emerging AI and digital technologies into project management practices
• Minimum 5-8 years of relevant experience and a BA or BS in Life Sciences or related disciplines preferred.
• Relevant experience consists of cross-functional work in biopharmaceutical /pharmaceutical CMC development and commercial teams, GMP environment and regulatory affairs
• Prior experience in project management required; PMP certification desirable
• Solid understanding of project management methodologies, tools, and techniques (Planisware familiarity is a plus )

The pay rate range for this role is $80 - $88/hr on w2

Regards

Satya S

Sr. Operations Manager

Phone #: View phone number on click.appcast.io

View email address on click.appcast.io