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Sr. Project Manager, CMC

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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Average salary estimate

$192500 / YEARLY (est.)
min
max
$186000K
$199000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Sr. Project Manager, CMC, Vaxcyte

Are you looking for an exciting opportunity to make a significant impact in vaccine development? Vaxcyte is seeking a passionate and experienced Sr. Project Manager, CMC to join our team in beautiful San Carlos, California. In this role, you will play a pivotal part in steering complex CMC project management activities for our clinical-stage vaccine innovation efforts. Your main mission will be to ensure that all internal and external CMC development and manufacturing activities are executed on time and within scope. Collaborating with diverse cross-functional teams, you will develop detailed timelines, track progress towards key milestones, and ensure that all deliverables align with corporate objectives. Your expertise will also shine as you lead coordination meetings, manage project documentation, and clearly communicate status updates to stakeholders. The work you do will directly contribute to our groundbreaking initiatives aimed at combating bacterial diseases. If you have a strong background in life sciences, along with robust project management skills, this is your chance to join a company that values innovation, leadership, and excellence. Join us at Vaxcyte and help us protect humankind—your adventure awaits!

Frequently Asked Questions (FAQs) for Sr. Project Manager, CMC Role at Vaxcyte
What are the key responsibilities of a Sr. Project Manager, CMC at Vaxcyte?

As a Sr. Project Manager, CMC at Vaxcyte, your key responsibilities include developing detailed project timelines for CMC components, leading cross-functional coordination meetings, ensuring operational plans are tracked, and managing external contract manufacturing organizations. You'll also contribute to program timelines and facilitate effective communication among stakeholders to ensure alignment with project objectives.

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What qualifications do I need to apply for the Sr. Project Manager, CMC position at Vaxcyte?

To apply for the Sr. Project Manager, CMC position at Vaxcyte, you need a BA/BS degree in a relevant field such as life sciences, engineering, or business administration, with an advanced degree preferred. Additionally, you'll need a minimum of 9 years of experience in the pharmaceutical or biotechnology industry, with at least 3 years in a CMC organization, and ideally hold a PMP Certification or project management training.

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How does the Sr. Project Manager, CMC at Vaxcyte interact with other teams?

The Sr. Project Manager, CMC at Vaxcyte plays a crucial role in facilitating collaboration between different teams. You'll lead cross-functional meetings, manage team documentation, and ensure that all team members are informed about project activities, timelines, and potential risks, fostering an inclusive environment for effective collaboration.

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What projects will I be managing as a Sr. Project Manager, CMC at Vaxcyte?

As a Sr. Project Manager, CMC at Vaxcyte, you will manage projects related to the development and manufacturing of innovative vaccines targeting bacterial diseases. Your work will involve both internal and external resources to ensure that all aspects of the project—such as process development, analytical development, and quality assurance—are executed effectively to meet regulatory standards and timelines.

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What personal skills are important for a Sr. Project Manager, CMC at Vaxcyte?

Important personal skills for a Sr. Project Manager, CMC at Vaxcyte include strong analytical skills, excellent planning and tracking abilities, effective communication skills, and the capability to manage multiple projects simultaneously. Additionally, conflict resolution, team management, and influence management skills will be essential for success in this role.

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Common Interview Questions for Sr. Project Manager, CMC
What experience do you have in CMC project management?

Discuss specific projects you've managed within a CMC setting, highlighting your roles, responsibilities, and how you ensured timely deliverables and adherence to budgets. Provide examples of challenges faced and how you overcame them.

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Can you describe your experience with cross-functional teams?

Provide examples of how you've worked with diverse teams across different functions. Focus on your communication style, conflict resolution strategies, and how you facilitated collaboration to achieve project goals.

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How do you manage project risks and ensure timely deliverables?

Explain your methodology for risk management, including how you identify potential risks early in the project lifecycle, the steps you take to mitigate these risks, and how you communicate these risks to stakeholders.

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How do you prioritize tasks in a fast-paced project environment?

Share your approach to prioritizing tasks, discussing tools or methods you use to manage competing deadlines and resources effectively. Provide insights on how you align priorities with overall project objectives.

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What tools do you prefer for project management and tracking?

Mention the tools you've used in previous roles, such as MS Project, Veeva, or Smartsheet, and explain how these tools help you manage timelines, track deliverables, and communicate with your team.

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Describe a challenging project you managed. What did you learn?

Select a specific project, discuss the challenges faced, and articulate what you learned in terms of project management skills, stakeholder management, or technical knowledge that you can apply to future projects.

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How do you ensure compliance with cGMP regulations during a project?

Explain your understanding of cGMP regulations and how you integrate compliance into project planning and execution. Provide examples of how you've ensured all aspects of the project meet these standards.

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How do you handle conflicts within a project team?

Describe a specific instance where you faced team conflict, your approach for resolving it, and the outcome. Emphasize your communication strategies and ability to foster a cooperative environment.

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What strategies do you use for effective stakeholder communication?

Discuss your communication style and the strategies you employ to keep stakeholders informed about project status, risks, and changes. Provide examples of how you tailor your communication based on audience needs.

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How do you ensure that external vendors meet their deliverables?

Discuss your experience in managing contracts with external CMOs and your strategies for maintaining oversight on deliverables. Share how you establish clear Statements of Work (SOW) and monitor progress closely.

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Vaxcyte is a people-first organization inspired by an audacious mission to develop best-in-class vaccines to prevent a host of deadly infectious diseases.

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Full-time, on-site
DATE POSTED
December 18, 2024

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