Role Summary
The Sr. Manager, Project Management will support the CMC team to ensure cross-functional planning is incorporated in department activities, identify risks and mitigation plans, and proactively address resource needs. This role requires effective communication 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 for content accuracy
- Contribute to long-range planning and budget planning; work with Legal and Finance to drive and manage vendor contracts and purchase orders
- Effectively manage multiple responsibilities and deliverables concurrently
Qualifications
- M.S. or B.S. in chemistry, chemical engineering, or equivalent preferred. Demonstrated understanding of the science behind drug development is required
- A minimum of 10 years of biotech/pharma industry project management
- Track record of delivering in a fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient
- Expert planning and tracking skills, able to see the big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management concerning priorities, and self-management
- Ability to work strategically and independently with internal and external groups on various projects
- This position may require some travel (<10%) as appropriate
Education
- See Qualifications (M.S. or B.S. in chemistry, chemical engineering, or equivalent preferred)
Additional Requirements
- This hybrid role requires in-office collaboration 2-3x per week in San Francisco