Senior Manager, Quality Control, Reference Standards
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.
Our Core ValuesWe are guided by four enduring core values that shape our work:
- Rethink Convention: We bring creative and intellectual diversity to every facet of our work 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.
We are seeking a Senior 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.
Key Responsibilities- 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.
- 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/BS with 8+ years of experience, including significant experience in reference standard management.
- 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.
Associate Director, Quality Control, Reference Standards
LocationSan Carlos, CA
CompensationThe compensation package will be competitive and includes comprehensive benefits and an equity component.
The salary range is $180,000 - $187,000.
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San Carlos, California, United States BioSpace, Inc. Full timeJob SummaryVaxcyte is seeking an experienced Associate Director to lead the quality control team in managing reference standards and critical reagents. The successful candidate will be responsible for developing and implementing policies, procedures, and strategies for global reference standard and critical reagent management systems.Key...
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