Sr. Manager, Project Management

Role Summary

The Sr. Manager, Project Management reports to the Director, Program Management and supports the CMC team to ensure cross-functional planning is incorporated in department activities. Identifies risks and mitigation plans, ensures resource needs are addressed proactively, and communicates effectively with internal stakeholders and external partners.

Responsibilities

• Organize and coordinate CMC/QA team activities and deliverables; manage weekly team meetings; prepare agendas and track action items
• Interface and manage multiple CDMOs to drive manufacturing activities in alignment with CMC timelines and clinical and commercial supply needs
• Ensure adherence to agreed-upon team goals and deliverables; coordinate drafting of sections of regulatory filing and cross-functional reviews; organize document QC processes to ensure content accuracy
• Contribute to long-range planning and budgetary planning; work with Legal and Finance to drive and manage vendor contracts and purchase orders
• Effectively manage multiple responsibilities and deliverables concurrently

Qualifications

• Required: M.S. or B.S. in chemistry, chemical engineering, or equivalent; demonstrated understanding of the science behind drug development
• Required: Minimum of 10 years of biotech/pharma industry project management
• Required: Track record of delivering in a fast-paced, innovative, dynamic environment; flexible, proactive, resourceful, and efficient
• Required: Expert planning and tracking skills; well-organized with strong time management; ability to manage multiple projects and priorities
• Required: Ability to work strategically and independently with internal and external groups on various projects
• Travel: This position may require some travel (<10%) as appropriate

Education

• MS or BS in chemistry, chemical engineering, or equivalent (as above)

Skills

• Cross-functional collaboration and stakeholder management
• Strategic thinking with strong execution and operational discipline
• Effective communication with internal teams and external partners
• Regulatory filing familiarity and document quality control processes
• Budgeting and vendor/contracts management

Additional Requirements

• In-office collaboration 2-3x per week in San Francisco (hybrid role)
• Hybrid work model with flexible, autonomous work arrangements