Associate Director
CMC Project Management
Confirmed live in the last 24 hours
Vaxcyte

201-500 employees

Develops broad-spectrum vaccines for bacterial diseases
Company Overview
Vaxcyte is a pioneering vaccine company that is redefining the production of complex immunizations through advanced synthetic techniques, including the XpressCFᵀᴹ cell-free protein synthesis platform, which is designed to expedite the creation and delivery of high-fidelity vaccines. The company's lead candidate, VAX-24, a broad-spectrum pneumococcal conjugate vaccine, has been granted FDA Breakthrough Therapy designation, demonstrating its potential in preventing invasive pneumococcal disease. With a culture focused on eradicating or treating invasive bacterial infections, Vaxcyte is leading the industry in developing vaccines with an expanded breadth of coverage, including candidates designed to prevent Group A Strep infections and slow the progression of periodontal disease.
Biotechnology

Company Stage

N/A

Total Funding

$2.2B

Founded

2013

Headquarters

San Carlos, California

Growth & Insights
Headcount

6 month growth

24%

1 year growth

56%

2 year growth

153%
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Management
Word/Pages/Docs
PowerPoint/Keynote/Slides
CategoriesNew
Business & Strategy
Product
Requirements
  • BA or BS degree in life sciences, engineering, or business administration
  • PMP Certification and/or Project Management training desired
  • Eight plus years of experience in the pharmaceutical or biotechnology industry with at least five years of relevant experience in a CMC organization
  • Solid understanding of CMC manufacturing and analytical activities required in biotech/drug/vaccine development, including knowledge of cGMP regulations
  • Direct experience leading and managing high-performing teams
  • Demonstrated aptitude for successfully managing multiple projects within 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
  • 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
Responsibilities
  • 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
  • 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
  • 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
  • Collaborate 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
Desired Qualifications
  • Advanced degree desired
  • Previous experience supporting regulatory filings a plus
  • Prior experience as a liaison with external manufacturing organizations strongly desired