Manager, QC Operations

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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 is looking for an energetic and talented individual to join our Quality Control team as a 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 for Vaxcyte's PCV product. The primary responsibility will include supporting of the quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations. The ideal candidate will apply technical expertise, strong cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches. The ideal candidate will have expertise in microbiological assays (bioburden, endotoxin, sterility and culture purity).
Essential Functions:

• Manage outsourced cGMP and characterization testing supporting lot release.
• Review and approve specification documents, Certificates of Analysis and release reports from CMOs.
• Collaborate with ADQC and interface with key stake holders to understand methods being performed onsite and at CMOs.
• Apply technical and compliance expertise to the review of test methods and in-process/release documentation and provide technical and compliance feedback to internal and external stakeholders who have developed the analytical methods.
• Serve as the technical expert for QC microbiological assays.
• Manage sample submission forms, shipping and sample handling activities required between the CMOs to support on time validation, testing and release of Vaxcyte components.
• Accountable for execution of quality control testing and supportive processes including sample /inventory management, scheduling, documentation, compliance review, results reporting (CoA), and scientific interpretation of data / method performance to ensure high quality data and control of methods.
• Author and review internal Certificates of Analysis and SOPs related to Quality Control policies and procedures.
• Responsible for quality event management (deviations, investigations, change control) related to QC operations.
• Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability.

Requirements:

• MS or BS with 7+ years of industry experience in Pharma / Biotech industry required.
• Understanding of various analytical chemistry methodology principles and experience with GMP release testing. Knowledge of microbial control methods (e.g. Bioburden, Endotoxin, Sterility, Growth Promotion). Previous experience in analytical method development, validation and transfer is highly desirable.
• Have solid understanding of various analytical technology used for analysis of proteins, conjugates, small molecules, and other large molecules. Able to apply the knowledge and understand gain in depth understanding of variety of methods in place for components used in Vaxcyte vaccine programs.
• Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements "best practices" or leading-edge quality standards.
• Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
• Solid understanding of relevant cGMPs, FDA, EU, and ICH regulatory guidelines as applicable to QC operations related to small molecules, biologics, and vaccines.
• Ability to work globally with CMOs in different countries and continents.
• Self-starter and resourceful problem solver, able to move up learning curve with some guidance and map out intermediate milestones to achieve personal goals.
• Strong interpersonal skills including the ability to communicate effectively both verbally and in written formats.
• Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.

Reports to: Director, Method Transfer & Quality Control

Location: San Carlos, CA

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

Salary Range: $150,000 - $174,000

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