Process Engineer II, MSAT

Company Profile: 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, carrier-sparing pneumococcal conjugate vaccine (PCV) 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-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella.
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 180 employees and anticipates continued, significant growth.
Following equity offerings in October 2022 and April 2023, which generated over $1.
1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24.
These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older.
The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children.
VAX-24 is being investigated for the prevention of 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-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease.
We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
Summary: We look forward to welcoming a Bioprocess Engineer with a solid understanding of bio-chemical engineering fundamentals and modeling expertise to support our laboratory, pilot and clinical scale process development, technology transfer to internal and external GMP production facilities for our novel cell free expression-based therapies.
Our team’s goal is to develop and implement robust commercial manufacturing processes.
This Process Engineer role requires close working relationships with Manufacturing, Analytical Development, Supply Chain, Quality, Regulatory and CMC Program Management functions as well as with external CMO teams.
We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations (e.
g.
bioreactors, chromatography, UF/DF, normal flow filtration, mixing and novel harvesting systems).
The ideal candidate should have a strong engineering background and understanding of these unit operations and will focus on pro-active process improvements and optimization, effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations and implement appropriate controls to ensure robust commercial manufacturing.
These skills should be complemented with a track record of excellent written and oral communication skills required to operate within a Quality Management System.
A history of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.
Success in this role would be demonstrated by effective participation in process design/development, optimization, investigations, and performance of experiments to identify/confirm associated root causes, followed by characterization and implementation of effective process changes to increase success in commercial production.
This position bears the potential for significant growth in a dynamic organization.
Essential Functions: Engineer new and modify existing processes to ensure right first-time process start-up and successful new product launches.
Leverage mass transfer, mixing principles and modeling towards effective scale-up of the process and transfer to GMP sites.
Represents MSAT on project teams as technical subject matter expert (SME) and interface with Pilot Plant, Manufacturing, Supply Chain, Facilities Engineering and Quality functions as well as external partners.
Develop process understanding and expertise.
Authors, reviews, and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc).
Authors, reviews change controls including managing change implementation.
Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ new product launches.
Collaborate with impacted groups to drive implementation of CAPAs from approval to closure.
Monitors and reports on process performance data analysis.
Ability to share 24/7 on call support activities during production.
Apply Operational Excellence principles to lead continuous improvement for process improvements.
Requirements: Masters (or Bachelors) degree in Engineering with 0-3 years of pharmaceutical/biotech experience.
Proven ability to multi-task, record of accomplishment and self-directed leadership in academia and/or industry setting is required.
Self-directed with effective analytical and problem-solving skills.
Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders.
Good interpersonal, team, and collaborative skills are required.
Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
Familiarity with Excel, Word, and PowerPoint and basic statistical techniques are required, experience in Statistical Design of Experiments, Python, CFD modeling is preferred.
All Vaxcyte employees require vaccination against COVID-19.
Reports to: Director, Protein Development and Clinical Manufacturing Location: San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $128,000 – $145,000 Send resumes to: careers@vaxcyte.
com Vaxcyte, Inc.
825 Industrial Road, Suite 300 San Carlos, CA 94070 We are an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.