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Analytical Project Manager, CMC

Vaxcyte

Vaxcyte

Operations
San Carlos, CA, USA
Posted on Nov 12, 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 a unique opportunity for an individual to blend analytical knowledge and skills with project management to enable the Analytical Development and Quality Control (AD/QC) organization. The successful candidate will provide analytical leadership, project management, technical, and quality knowledge to all phases of clinical and commercial development for Vaxcyte’s vaccine programs.

Essential Functions:

  • Responsible for coordination and management of analytical activities of Vaxcyte’s clinical products as well as to provide scientific analytical support, as needed.
  • Potential to draft protocols, coordinate execution and testing of samples, and summarize the results and draft final reports.
  • Provide CMC Project Management for both internal and external CMC analytical activities to ensure deliverables are achieved on time, within scope, and on budget.
  • Responsible for CMC component analytical activities relating to the program ensuring they are completed in the required timelines and in accordance with cGMP quality systems.
  • Guide and/or author the generation of key QC documentation to support testing and reporting of analytical data.
  • Life-cycle management of analytical methods and analytical support for Quality Control, Production, and Regulatory filings.
  • Enable and ensure adherence to 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.
  • Own business milestones for projects, provide timely identification and escalation of at-risk milestones using business tools and drive remediation or mitigation.
  • 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.

Requirements:

  • BA or BS degree in life sciences, engineering, or business administration; advanced degree desired.
  • PMP Certification and/or Project Management training desired.
  • Five to seven years of experience in the pharmaceutical or biotechnology industry with at least two years of relevant experience in an analytical organization, including significant experience in a cross-functional team environment.
  • Sound knowledge of analytical science, technical and regulatory expectations at all clinical phases including validation, analytical qualification, reference standard maintenance, and vaccine release testing.
  • Prior experience working in, or as a liaison with, contract testing 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.
  • 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/ Open to Remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $140,000 - $172,000 (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.
Apply now
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