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The Associate Director of Quality Control will manage global reference standards and critical reagents, ensuring compliance with ICH guidelines. They will lead policy development, oversee technical documentation, and collaborate with CMC, QA, and RA teams for clinical and commercial product testing and release.
Vaxcyte is seeking a Scientist II, Conjugation Development to contribute to process characterization efforts for pneumococcal conjugate vaccine program and work on conjugation process development for pipeline programs. Responsibilities include preparation, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates.
The Sr. Associate Scientist will contribute to the research and development of a novel bacterial polysaccharide conjugate vaccine, focusing on developing and optimizing scalable purification processes. Responsibilities include utilizing various chromatography techniques, analyzing polysaccharides, maintaining laboratory records, and collaborating with internal and external teams.
The Sr. Scientist in Analytical Development will lead the development and qualification of analytical methods for vaccine targets. Responsibilities include developing methods, conducting characterization studies, overseeing CRO/CMO collaborations, and authoring protocols and reports while mentoring junior team members.
The Group Leader in Analytical Development will manage a team focused on R&D stability studies and assay control qualification. Responsibilities include lab operations oversight, technical mentorship, experiment design, data communication, and ensuring compliance and quality in testing processes.
The Stability Manager will oversee the stability program within Vaxcyte's Vaccine Product Development, managing stability studies, analyzing stability data, and ensuring compliance with regulatory guidelines. This role requires collaboration with cross-functional teams and involves developing stability protocols, creating reports, and presenting findings to ensure project milestones are met.
The Associate Engineer I will support the polysaccharide development and manufacturing group by conducting downstream process development experiments, operating laboratory equipment, conducting assays, maintaining records, and participating in technical discussions while collaborating with the CMC team.
Seeking a Sr. Manager for Quality Control Reference Standards team to oversee management and supply of reference standards for clinical and commercial products. Ensure compliance with global regulatory guidelines and support pipeline of high-fidelity vaccines.
The Document Control Specialist at Vaxcyte is responsible for managing and maintaining quality systems documentation related to vaccine manufacturing in a GXP compliant environment. This role involves overseeing the lifecycle of GMP documents in Veeva, collaborating with quality assurance and project management teams, and supporting audits while ensuring compliance with regulatory standards.
The IT Operations Engineer provides high-quality technical support to onsite and remote employees, focusing on exceptional customer service while resolving hardware, software, and network issues. Responsibilities include managing IT tickets, user account management via Okta, supporting Microsoft 365 applications, and maintaining A/V equipment in conference rooms.
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