Associate Director, Quality Control, Reference Standards

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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:

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.

Summary:

Vaxcyte seeks an energetic and talented individual with profound experience in reference standards and critical reagent management to join our quality control team as an Associate Director/Senior QC Manager. The position will be an integral part of the team responsible for cGMP compliance in routine operations for all phases of clinical development and commercial for Vaxcyte vaccine programs.

The successful candidate will report to the Senior Director of QC, be part of the Quality Control Extended Leadership team, and establish policy and strategy in managing the reference standards and critical reagents in compliance with ICH guidelines. The successful candidate must demonstrate strong reference standard management skills and statistical and technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a solid commitment to quality, compliance, and scientific excellence.

This position will establish and maintain the global program management of reference standards and critical reagents for testing and releasing clinical and commercial products. This position will collaborate with internal CMC, QA, and RA functional teams and external partners (CDMOs/CTLs) to ensure the global network's continuous supply of qualified Reference Standards and Critical Reagents.
Essential Functions:

• Act as the main point of contact in the Vaxcyte QC organization and responsible for the developing and implementation of policies, procedures, and strategies for Vaxcyte's global reference standard and critical reagent management systems to support continuous testing and the release of clinical and commercial products.
• Lead the development of global business practices, policies, and standards for reference standards and critical reagents, including qualification/requalification, resupply, and inventory management.
• Author or oversee the authoring of technical protocols, qualification reports, requalification reports, and expiry extension reports for reference standards and critical reagents.
• Oversee the monitoring of manufacturing schedules, request materials for reference samples and critical reagents, and coordinate support activities.
• Establish and maintain the trending program for reference standards and critical reagents in collaboration with internal teams and external partners. Responsible for reviewing and managing OOS/OOT and deviations and developing strategies and decisions in risk mitigation around reference standards and critical reagents.
• Develop, manage, and optimize processes and projections for critical reagent supply planning, including inventory management, logistics, and space planning.
• Collaborate with internal teams (Process Development, Quality, Regulatory, Supply Chain, and Commercial) and external partners (CDMOs/ CROs/ CTLs) to continuously supply qualified reference standards and critical reagents.
• Oversee or coordinate the generation of critical reagents with other support areas and external contractors as needed.
• Apply technical and compliance expertise in reviewing test methods and in-process/release documentation, providing technical and compliance feedback to internal and external stakeholders.
• Author and review internal Certificates of Analysis and SOPs related to Quality Control policies and procedures.

Requirements:

• Ph.D. with 8+ years of AD/QC experience or MS/BS with 12+ years of AD/QC experience, including 5+ years in reference standard management within the vaccine, biotech, or pharma industry.
• Strong understanding of relevant cGMP, FDA, EU, and ICH regulatory guidance associated with release and characterization assays.
• Strong knowledge of regulatory requirements and quality standards in the pharmaceutical industry.
• Broad experience with biochemistry, immunoassay, biological, and microbiological assays.
• Strong biostatistics background for evaluating comparability and qualification of reference standards. Experience with LIMS, analytical statistics, and statistical software (e.g., JMP).
• Ability to work globally with external suppliers (CDMOs/ CROs/ CTLs) in a team-oriented environment under dynamic conditions.
• Ability to work in a fast-paced team environment and to consistently meet aggressive timelines while prioritizing tasks for multiple projects.
• Self-starter with strong problem-solving skills and excellent interpersonal communication abilities.
• Strong written and verbal communication skills, and efficient in communicating with inter-disciplinary and cross-functional teams.
• Good organization and planning skills.

Reports to: Senior Director, ASAT for Quality Control

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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