Vaxcyte
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The Quality Assurance Manager will lead all manufacturing activities related to Process Validation and GMP Manufacturing. Responsibilities include maintaining Quality Systems documentation in Veeva, managing GMP document lifecycles, supporting audits, and collaborating across functions to ensure compliance with regulatory standards related to vaccine production.
The Manager of Quality Assurance will oversee the manufacturing activities related to process validation and GMP manufacturing for Vaxcyte's products. They will ensure compliance with regulatory requirements, collaborate with various functions, and drive the establishment of quality agreements while troubleshooting issues with contract manufacturers.
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.
The Associate Director, Process Analytics will serve as an analytical expert within the Conjugation team, providing leadership in analytical method development, validation, and optimization for biopharmaceutical processes. Responsibilities include reviewing QC methods, analyzing manufacturing data, authoring regulatory filings, and coordinating in-process testing to ensure methods meet process requirements.
As a Sr. Project Manager, CMC at Vaxcyte, you will oversee CMC development and manufacturing activities, ensuring project deliverables are met on time and within budget. You will lead coordination meetings, track progress towards milestones, communicate with stakeholders, and manage external contracts to support the company's vaccine innovation efforts.
The Sr. Manager of Quality Control at Vaxcyte will coordinate CMC activities related to Quality Control to ensure compliance and secure supply of innovative therapies. Responsibilities include creating QC strategies, maintaining quality control systems, overseeing method validation, managing data accuracy, and reviewing analytical data from contract laboratories.
The Associate Director of Quality Control oversees the management of CMC activities related to Quality Control for Vaxcyte’s innovative therapies, ensuring compliance with quality standards throughout the development and manufacturing processes. Responsibilities include implementing quality control systems, managing analytical testing methods, and collaborating with contract laboratories.
The Scientist II will design and execute in-house assays for polysaccharide analysis, maintain routine operations of analytical instruments, ensure testing compliance, and mentor junior scientists while collaborating with cross-functional teams.
The Sr. Manager of Supply Chain Planning at Vaxcyte will oversee end-to-end supply planning activities, including demand planning, inventory optimization, and scenario planning. This role requires collaboration across teams to align supply chain operations with business growth objectives, enhance efficiency, and manage supplier relationships effectively.
The Senior Director of Technical Accounting & SEC Reporting will lead technical accounting and external reporting, ensuring compliance with GAAP and SEC standards. They will oversee the preparation of SEC filings, manage audits, develop policies, collaborate with cross-functional teams, and mentor the accounting team, all while communicating complex topics effectively across the organization.
Seeking a Senior Manager, Quality Systems to ensure adherence to regulatory standards and continuous improvement. Responsibilities include implementing GxP systems, supporting regulatory compliance, collaborating with IT and cross-functional teams, monitoring quality metrics, preparing for inspections, and promoting a quality culture.
The Executive Assistant will provide support to the Sr. Vice President, General Counsel & Chief Compliance Officer, and Chief Business Officer. Responsibilities include managing calendars, organizing meetings and travel, preparing materials, and supporting team functions. They will prioritize initiatives, represent the company externally, and assist with various administrative tasks to ensure effective operations.
The Scientist I will support analytical activities in the laboratory, assisting in the design and execution of experiments, particularly focusing on analyzing proteins and carbohydrates through various assays and instruments, including HPLC and microplate assays. The role includes method development, data communication, and maintaining detailed experimental records.
The Senior Associate Scientist will lead the development and optimization of upstream processes for polysaccharide manufacturing using microbial fermentation. Responsibilities include experimental design, execution, and analysis of experiments to enhance yield and quality, performing microbiological work, and maintaining fermentation equipment while collaborating with cross-functional teams and reporting results.
The Sr. Scientist in Polysaccharide Analytical Development will design and execute assays for polysaccharide analysis, implement novel platforms, oversee assay automation, ensure quality compliance, and mentor junior scientists. Responsibilities include troubleshooting analytical methods and communicating data effectively across teams.
The Analytical Project Manager at Vaxcyte is responsible for overseeing analytical activities related to clinical products, providing scientific support, drafting protocols, and managing project timelines to ensure milestones are met according to quality standards. This role requires coordination between CMC and program team members, guiding key documentation, and addressing potential risks in a timely manner.
The Scientist II at Vaxcyte is responsible for developing analytical assays for bacterial polysaccharide conjugate vaccines, conducting routine testing, maintaining instruments, troubleshooting methods, and providing mentorship to junior scientists while ensuring quality and compliance of testing.
The Senior Project Manager will oversee ERP/APS system implementation and management to align with business objectives. Responsibilities include project planning, risk management, stakeholder collaboration, and ensuring timely delivery within budget, while fostering a collaborative team environment.
The Director, Tax will oversee tax accounting, reporting, and compliance at Vaxcyte. Responsibilities include managing federal and international tax compliance, advising on new legislation, partnering with external advisors, reviewing tax returns, and maximizing tax benefits. The role is crucial for the company's growth as it prepares for commercialization and potential international expansion.