Sr. Quality Control Manager, Method Validation and Transfer
Company: Vaxcyte
Location: San Carlos
Posted on: June 26, 2022
Job Description:
Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company
engineering high-fidelity vaccines to protect humankind from the
consequences of bacterial diseases. The Company is developing
broad-spectrum conjugate and novel protein vaccines to prevent or
treat bacterial infectious diseases. Vaxcyte's lead candidate,
VAX-24, is a 24-valent, broad-spectrum pneumococcal conjugate
vaccine being developed for the prevention of invasive pneumococcal
disease (IPD). The Company is re-engineering the way highly complex
immunizations are made through modern synthetic techniques,
including advanced chemistry and our exclusively licensed
XpressCFTM cell-free protein synthesis platform. Unlike
conventional cell-based approaches, the Company's system for
producing difficult-to-make proteins and antigens is intended to
accelerate its ability to efficiently create and deliver
high-fidelity vaccines with enhanced immunological benefits.
Vaxcyte's pipeline also includes VAX-XP, a PCV with an expanded
breadth of coverage of greater than 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. The Company is
driven to eradicate or treat invasive bacterial infections, which
have serious and costly health consequences when left unchecked.
For more information, visit www.vaxcyte.com.Vaxcyte, headquartered
in San Carlos, CA, went public in June 2020 and currently has a
team of approximately 100 employees and anticipates continued,
significant growth. On January 6, 2022, Vaxcyte announced that the
U.S. Food and Drug Administration (FDA) had cleared the
Investigational New Drug (IND) application for VAX-24, its lead
vaccine candidate. The Company initiated the VAX-24 Phase 1/2
clinical proof-of-concept study in adults in the first quarter of
2022 and expects to announce Phase 2 topline immunogenicity,
safety, and tolerability results by the end of the year. VAX-24 was
designed to prevent IPD, which can be most serious for infants,
young children, older adults and those with immune deficiencies or
certain chronic health conditions. Given the global impact of
pneumococcal disease remains significant, the public health
community continues to advocate for vaccines that can offer broader
protection to prevent IPD. Vaxcyte's PCV franchise, consisting of
VAX-24 and VAX-XP, is designed specifically to address this need
and has the potential to deliver the broadest protection for this
very serious disease.Essential Functions:
- Collaborate with Analytical Development and interface with key
stake-holders to determine when a method is suitable for method
qualification/validation.
- Contribute to and implement the high level method qualification
and validation strategy decided by CMC executive team.
- Collaborate with CMOs and CTLs to design an effective method
qualification/validation plan, and lead method
qualification/validation activities to ensure campaign
readiness.
- Review and approve method qualification and validation
protocols and reports, may need to author method
qualification/validation protocols and reports.
- Evaluate analytical method readiness for transfer, provide
technical and compliance feedback to internal and external
stakeholders who have developed the analytical methods.
- Collaborate with Analytical Develop Scientists, Formulation,
Process Development, Conjugation to gain the necessary method and
product knowledge.
- view analytical method development data, reports and method
document to be transferred to CMOs.
- Responsible for quality event management (deviations,
investigations, change control) related to method
qualification/validation.
- Provide technical and strategic functional oversight, including
resource management for method validation and transfer.
- Accountable for execution of method validation and transfer and
supportive processes including sample planning, scheduling,
documentation, compliance / technical review and scientific
interpretation of data to ensure the successful
validation/qualification/transfer of methods.
- Responsible for method qualification/validation for raw
materials, intermediates, DS and DP for various projects in the
Vaxcyte pipeline.
- Manage outsourced Qualification/Validation of methods at CMOs
or CTLs.
- upport 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.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;
- Understanding of various analytical chemistry methodology
principles and successful track record of method transfer, trouble
shooting and validation for GMP release and stability 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 understand gain in
depth understanding of variety of methods placed for 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;
- 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.
- 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.
- 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.
- All Vaxcyte employees require vaccination against
COVID-19.Reports to: Associate Director, Method Transfer and
Quality ControlLocation: San Carlos, CACompensation:The
compensation package will be competitive and includes comprehensive
benefits and an equity component.Send resumes
to:careers@vaxcyte.comVaxcyte, Inc.825 Industrial Road, Suite
300San Carlos, CA 94070
Keywords: Vaxcyte, San Francisco , Sr. Quality Control Manager, Method Validation and Transfer, Executive , San Carlos, California
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