- Collaborate with CMOs to ensure release testing requirements are being met at the agreed upon timelines.
- Review and approve specification documents, Certificates of Analysis and release reports from CMOs. May need to author internal SOPs related to Quality Control policies and procedures.
- Generate Internal CoAs and CoTs and trend release results and system suitability criteria
- Apply technical expertise to the review of method validation, transfer and release documentation.
- Manage sample submission forms, shipping and sample handling activities required between the CMOs to support on time validation, testing and release of Vaxcyte components.
- Responsible 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.
- Responsible for quality event management (deviations, investigations, change control) related to QC operations.
- Support audits, inspections, and health authority responses.
- Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
- Provide strong teamwork in establishing a quality culture and shared accountability.
- Collaborate with ADQC and interface with key stake holders to understand methods being performed onsite and at CMOs.
Requirements: - MS or BS with 7-10/years of industry experience in Pharma / Biotech industry required.
- Understanding of various analytical chemistry methodology principles and experience with method transfer, trouble shooting, validation and/or GMP release testing.
- 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 gain an 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.
- Awareness of relevant FDA, EU, and ICH regulatory guidelines as applicable to QC operations related to small molecules, biologics and vaccines, and expiry dating.
- Understanding of how regulatory guidance shapes industry approaches to phase appropriate analytical transfer, validation strategies, and QC practices.
- Self-starter and resourceful problem solver, able to move up learning curve with some guidance and map out intermediate milestones to achieve personal goals.
- Technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOP preferred.
- Strong interpersonal skills; 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.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Senior Manager, Quality Control Method Validation & Transfer
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $150,000 – $168,000
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Quality Control Manager - San Carlos, United States - Vaxcyte, Inc.
Description
Join our Mission to Protect HumankindVaxcyte 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.
Essential Functions:
