Manager/Sr. Manager, QC Operations
- Employer
- Vaxcyte, Inc.
- Location
- Foster City, California
- Start date
- Dec 1, 2021
View more
- Discipline
- Manufacturing & Production, Operations, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.
Summary
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as Manager/Sr. Manager of QC Operations.
The position will be an integral part of the team implementing and maintaining cGMP-compliance in routine operations for all phases of clinical development. The primary responsibility will include having oversight of the quality control including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations. This individual will collaborate with QC Leaders to build systems/processes to establish and achieve product release cycle times and deliverables in a highly collaborative and cross-functional environment. The ideal candidate will apply strong cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches
Essential Functions
- Collaborate with Quality team and interface with key stake-holders to establish and maintain cGMP-compliant quality control operations, including establishing a new QC laboratory (programming, equipment purchase/qualification, process documentation) as needed.
- Provide technical and strategic functional oversight, including resource/operational management for all QC areas (physicochemical, biological and microbial).
- Accountable for execution of quality control testing and supportive processes including sample and 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.
- Establish processes control, charting and trending of lot release data
- Establish processes, controls and metrics within QC operations for life cycle management of methods and programs
- Manage qualification and retest of critical reagents and reference standard program
- Collaborate with QC of Method Transfer and Validation to support related activities
- Manage outsourced cGMP testing supporting lot release
- Accountable for quality event management (deviations, investigations, change control).
- Support audits, inspections and health authority responses
- Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions
- Provide strong teamwork in establishing a quality culture and shared accountability. Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance
- All Vaxcyte employees require vaccination against COVID-19
Requirements
- MS or BS with 7-10 years of industry experience in Pharma / Biotech industry required
- Demonstrate sound complex decision making skills and exhibit good judgment. Make decision with understanding of the strategic context and short and long term impact of decisions on other departments or functional areas before making them; able to decide and act effectively without having the whole picture;
- Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards;
- Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management
- Track record of building strong functional team, able to leverages understanding of strengths and weaknesses of team members in positioning them in the team; ability to anticipate and implements changes in roles and accountabilities in response to changes in the work environment; ensures teams have the right mix of talent and resources to meet/exceed goals;
- Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics
- Expert analytical skills for integrating and interpreting interdisciplinary project information; thorough understanding of the drug/vaccine development process
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to analytical method qualification/validation for small molecules, biologics and vaccines, stability study design and expiry dating
- Demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical transfer, validation and stability strategy
- Ability to work globally with CMOs in different countries and continents
- Understanding of various analytical chemistry methodology principles and successful track record of method transfer, trouble shooting and validation for GMP release and stability testing, as well as stability study design and expiry/shelf life establishment
- Self-starter and resourceful problem solver, able to move up learning curve independently and map out intermediate milestones to achieve project goals.
- Experience in IND, NDA and BLA submission is highly preferred
- Extensive technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOPs
- 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
Reports to: Director, Quality Control
Location: San Carlos, CA
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Vaxcyte, Inc.
825 Industrial Rd.
Suite 300, San Carlos, CA 94070
Company
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.
- Website
- https://vaxcyte.com/
- Phone
- (650) 837-0111
- Location
-
825 Industrial Road, Suite 300
San Carlos
CA
94070
US
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert