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Associate Director, CMC Project Management

Employer
Vaxcyte, Inc.
Location
San Carlos, California
Start date
Mar 16, 2024

View more

Discipline
Clinical, Clinical Project Management, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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:

*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.

*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.

*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
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.

Reports to: Executive Director, CMC and General Project Management
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $190,000 - $195,000
 
 

Company

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.

Company info
Website
Phone
(650) 837-0111
Location
825 Industrial Road, Suite 300
San Carlos
CA
94070
US

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