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Sr. Project Manager, CMC

Vaxcyte

Vaxcyte

Operations
San Carlos, CA, USA
Posted on Dec 17, 2024
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Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte has an exciting opportunity for a Sr. Project Manager, CMC to join our Project Management team! In this role, you will provide 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.

Essential Functions:

  • 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. Manage execution of SOWs and track progress and completion of deliverables.
  • Identify and implement processes/tools to continuously improve and streamline the workflow of CMC project management and coordination teams.

Requirements:

  • BA/BS degree in life sciences, engineering, or business administration; advanced degree desired.
  • Minimum of 9 years of experience in the pharmaceutical or biotechnology industry with at least three years of relevant experience in a CMC organization, including significant experience working in a cross-functional team environment.
  • PMP Certification and/or Project Management training desired.
  • 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.
  • Prior experience as a liaison with external manufacturing organizations desired.
  • 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 manage complex projects independently and ability to manage 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.
Reports to: Associate Director, CMC Project Management
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $186,000 – $199,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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