Senior Manager, Quality Control, Reference Standards

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, 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:

We are seeking a Sr. Manager for our Quality Control (QC) Reference Standards team to oversee the management and continuous supply of reference standards and critical reagents for testing and releasing clinical and commercial products. This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines.

The Sr. Manager will work closely with internal teams (Process Development, Quality Assurance, Regulatory, Supply Chain, and Commercial) and external partners (CDMOs, CTLs, and CROs) to maintain the integrity of the reference standard program.

Essential Functions:

• Reference Standards Management: Oversee the implementation and maintenance of the reference standards and critical reagent program, ensuring compliance with cGMP and ICH guidelines.

• Program Development: Support the development of global business practices, policies, and standards for reference standards and critical reagents, including qualification, requalification, and inventory management.

• Documentation and Compliance: Collaborate in the authoring and review of technical protocols, qualification reports, requalification reports, and Certificates of Analysis (CoAs) related to reference standards. Ensure timely updates to SOPs and other relevant documentation.

• Inventory Management: Manage supply chain logistics, including inventory and space planning, to ensure a continuous supply of qualified reference standards and critical reagents.

• Collaboration and Communication: Serve as a key point of contact within Vaxcyte QC and with external partners, fostering productive collaborations to support the company's vaccine programs.

• Technical Expertise: Provide technical guidance on assay qualification and validation to meet regulatory standards, and review test methods and release documentation for reference standards.

• Quality Oversight: Review and manage deviations, OOS/OOT results, and conduct risk assessments related to reference standards and critical reagents.

Requirements:

• Bachelor’s, Master’s, or Ph.D. in Biochemistry, Chemistry, or a related field. Ph.D. with 5+ years of relevant QC experience, or MS with 7+ years of experience, or BS with 9+ years of experience, including significant experience in reference standard management. Other combinations of education and/or experience may be considered.

• Strong background in cGMP and ICH regulatory guidance associated with reference standards and critical reagents.

• Experience working with biochemistry, immunoassay, or microbiological assay techniques.

• Familiarity with statistical software (e.g., JMP) for data analysis, trending, and process optimization.

• Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.

• Strong written and verbal communication skills, including the ability to work effectively in cross-functional teams.

• Proficiency in LIMS and other laboratory data management systems is preferred.

Reports to: Senior Director, Global Analytical Sciences and Technology (ASAT) Lead

Location: San Carlos, CA; Open to Remote

Compensation:

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

Salary Range: $176,000 – $205,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.