Associate Director, Process Analytics

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Job description

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 an Associate Director, Process Analytics to join their Conjugation team.
Essential Functions:

• Serve as analytical SME for Conjugation department, representing the department in various cross-functional teams and meetings.
• Review QC method validation protocols and reports to ensure that test method performance meets the needs of the process - if not, collaborate with QC team to bring performance up to process requirements.
• Analyze manufacturing and stability data to identify trends in the process or analytical method performance.
• Contribute to specification setting strategy using analysis of prior data and method performance.
• Contribute to authoring and review of CMC sections in regulatory filings.
• Contribute to analytical method development and optimization for new pipeline programs.
• Coordinate characterization and in-process testing performed within the group.
• Ensure analytical methods used for process development are fit for purpose.

Requirements:

• PhD in Chemistry/Biochemistry or similar, with 7+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience.
• Extensive experience in analytical method development, validation, and implementation for biopharmaceutical processes.
• Strong knowledge of analytical techniques such as HPLC and colorimetric assays.
• Experience working with bioconjugates or with regulatory submissions is a plus.
• Proven track record of leading and managing analytical projects in a biopharmaceutical or biotechnology setting.
• Excellent judgment when assessing risk - strong understanding of when to expend resources to reduce risk and when the level of risk is acceptable to move forward.
• Excellent problem-solving skills and ability to work in a fast-paced, dynamic environment.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strong sense of organization, preferably with experience managing timelines using a tool such as Microsoft Project.
• Strong ability to motivate, mentor, and connect with junior team members.
• Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.

Reports to: Senior Director, Conjugation Development & Clinical Manufacturing

Location: San Carlos, CA

Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $190,000 - $197,000 (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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