Sr. Manager, Project Management

What You'll Do

The Senior Manager, Project Management will report to the Director, Program Management, and support the CMC team to ensure that cross-functional planning is incorporated in department activities, identified risks, mitigation plans are established to address the risks, and resource needs are identified and addressed proactively. The successful candidate must communicate effectively with internal stakeholders and external partners.

Responsibilities

•    Organize and coordinate CMC/QA team activities and deliverables; manage weekly team meetings; prepare agendas and keep track of action items

•    Interface and manage multiple CDMOs to drive manufacturing activities in alignment with CMC timelines and clinical and commercial supply needs

•    Responsible for ensuring adherence to agreed-upon team goals and deliverables.  Coordinate drafting of certain sections of regulatory filing and cross-functional reviews. Organize document QC processes to ensure accuracy of content

•    Contribute to long-range planning and budgetary planning.  Work with Legal and Finance departments to drive and manage vendor contracts and purchase orders

•    Effectively manage multiple responsibilities and deliverables concurrently

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco office. 

Who You Are

Historically the "Experience, Education, & Skills Requirement" section

(5-7 bullets max)

• M.S. or B.S. in chemistry, chemical engineering or equivalent preferred. Demonstrated understanding of 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 multiple projects
• This position may require some (<10%) amount of travel as appropriate