Quality Control Manager
2 days ago
Vaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines to safeguard humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. We are committed to a path of success, guided by four core values: Aim High, Lead with Heart, Rethink Convention, and Model Excellence.
Join Our Team as a QC ManagerWe are seeking an energetic and talented individual to join our Quality Control team as a QC Manager. The successful candidate 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 quality control activities, including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations.
Key Responsibilities:- 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 stakeholders 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.
- 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, and scientific interpretation of data/method performance.
- 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.
- MS or BS with 7+ years of industry experience in the 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.
- Result-oriented; good judgment in directing attention and effort across competing priorities, especially when resource-constrained.
- 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 the 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.
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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San Carlos, California, United States Vaxcyte Full timeProtect Humankind from Bacterial DiseasesVaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines to safeguard humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella.Our Core...
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