Essential Functions:

• Provide, and lead a team of project managers in providing, CMC Project Management for both internal and external CMC development and manufacturing activities to ensure deliverables are achieved on time, within scope, and on budget.
• Hire, train, and manage CMC Project Management team members to ensure project management support is successfully provided to CMC teams for projects ranging from pre-IND through clinical development and commercialization.
• Develop detailed timelines for CMC component project plan, identify risks and mitigating actions and communicate/escalate accordingly to ensure clarity of deliverables and timing to achieve overall product/project plan and corporate goals/objectives. 
• Lead CMC cross-functional coordination meetings, including scheduling and facilitating meetings, sending out agendas, writing and distributing meeting summaries, managing team documentation, and tracking goals and action items.
• Ensure operational plans are proactively tracked and highlight progress towards key milestones to ensure alignment of task dependencies associated with internal and external development and manufacturing activities. Responsible for efforts associated with process development, analytical development, manufacturing, quality, and supply chain.
• Work with CMC and program team members to operationalize CMC strategy and integrate into the cross-functional program schedule.
• Communicate with appropriate stakeholders to ensure project team and leadership are fully informed and knowledgeable of project activities, status, and potential risks.
• Contribute to program cross-functional working plans and timelines, help teams prioritize workstreams, proactively identify and mitigate risks, and ensure sufficient resourcing to achieve program goals.
• Build and manage trackers and dashboards to communicate real-time status of projects related to campaign manufacturing and analytical readiness, release and downstream use.
• Manage external CMOs through development of Statements of Work (SOW) contracts. Provide initial screening and work with Program Manager and internal technical subject matter experts, legal, and finance, as required, to define scope and budget.
• Identify processes/tools to continuously improve and streamline the workflow of CMC project management and coordination teams. Responsible for implementing shared tools and processes across the CMC Project Management team and the cross-functional CMC project teams.
• As a leader within the CMC Project Management team, you will play a key role in maintaining project management excellence. This includes collaborating on best practices, standardizing team management operations, maintaining alignment of program dashboards, and leading initiatives that enhance the program support we provide the CMC cross-functional organization.

Requirements:

• BA or BS degree in life sciences, engineering, or business administration; advanced degree desired.
• PMP Certification and/or Project Management training desired. Project Management experience required.
• Eight plus years of experience in the pharmaceutical or biotechnology industry with at least five years of relevant experience in a CMC organization, including significant experience in a cross-functional team environment.
• Solid understanding of CMC manufacturing and analytical activities required in biotech/drug/vaccine development, including knowledge of cGMP regulations. Previous experience supporting regulatory filings a plus.
• Direct experience leading and managing high-performing teams.
• Prior experience as a liaison with external manufacturing organizations strongly desired.
• Demonstrated aptitude for successfully managing multiple projects, of varying complexity, within the specified guidelines, timeframes, and budgets.
• Expert analytical skills for integrating and interpreting interdisciplinary project information.
• Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
• Demonstrated ability to lead other project managers in managing complex projects independently and managing changes in processes, strategy, and competitive landscape.
• Strong team management skills, including facilitation, conflict resolution, and team development.
• Proven influence management and communication skills, at all levels of the organization.
• Working knowledge of MS Word, Excel, PowerPoint, Visio, and Project.
• Working knowledge of Veeva and Smartsheet a plus.
• Excellent written and oral communication skills.
• All Vaxcyte employees require vaccination against COVID-19.