Sr. Engineer, Polysaccharide Manufacturing

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 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.
 
Summary:
 
We are looking for a Senior Engineer with late-stage clinical or commercial experience in manufacturing, process characterization, and process validation. The successful candidate must have the ability to work in a highly collaborative manner with both internal teams and our CMOs. We are looking for an outstanding team player with excellent communication skills to join the polysaccharide development and manufacturing group within the CMC team.
 
The Senior Engineer will work collaboratively with the process development team responsible for early-stage polysaccharide development and process optimization. The Senior Engineer will work with the team to define an appropriate process optimization and characterization strategy for the polysaccharide intermediates. This person will play a critical role in overseeing CMO activities including process transfer, process implementation, process validation and implementation of a process control strategy at the commercial facility to support BLA filing and commercial launch. The candidate should have demonstrated experience with overseeing manufacturing operations, root cause analysis, risk assessments, and identifying critical and non-critical performance parameters. This is a great opportunity to make an impact and interact cross-functionally to take Vaxcyte’s lead program to the next level toward the company’s first licensure application.

Essential Functions:

• Provide Manufacturing oversight.
• Review/approve key manufacturing documents such as BFD, PPL, BML etc.
• Work to close-out deviations and change requests with internal and CMO teams.
• Troubleshoot unexpected manufacturing problems.
• Serve as person in plant to observe key manufacturing operations.
• Compile manufacturing data and present to cross-functional teams.
• Technology/Process Transfer to external partners.
• Work with development team to generate transfer documents.
• Effectively interface with CMO teams to communicate key process information.
• Ensure process is delivering an intermediate with consistent purity and overall yield.
• Late Stage Process Development Planning.
o   Work with process development team to determine CQAs and CPPs utilizing risk assessment tools such as FMEA.
o   Write and contribute to process characterization, scale-up, process control and process validation documents.

• Participate in future manufacturing facility planning to ensure the delivery of enough polysaccharide per year to meet our commercial needs.
• Participate in study designs in order to explore identified process risks through experimentation
• Present/communicate data to polysaccharide team as well as broader CMC team.
• Contribute to technical discussions within the CMC team.
• Works within a team environment and provides support as necessary to further the team’s initiatives.

Requirements:

• PhD in Bioprocess Engineering, Chemical Engineering, Biotechnology or a related discipline, with 5+ years of industry experience or combination of industry and postdoctoral research; M.S. with 8+ years of industry experience; or B.S. with 10+ years of industry experience.
• ·Experience working at/with CMOs in a MFG setting:
o   Ability to travel internationally to a CMO as some international travel may be required.
o   Ability to effectively communicate process details and considerations.
o   Troubleshooting manufacturing problems and closing out deviations/change records.
o   Root cause analysis utilizing tools such as fish-bone diagram.

• Practical experience with and theoretical knowledge of traditional processing unit operations including Fermentation, TFF, depth filtration, continuous centrifugation, chromatography and micro-fluidization.
• Late-stage experience including;
o   Identification of CPPs and CQAs.
o   Risk assessment generation.
o   Process characterization experience.

• Demonstrated proficiency with engineering principles involved in scaling processes from lab to pilot scale.
o   Automation experience a plus.

• Proficient with computer programs such as Microsoft Excel, Word, Powerpoint, Visio and JMP.
o   Experience with process modelling software a plus.

• Demonstrated success working in a cross-functional team environment on multiple projects; ability to work effectively as a member of a team to deliver results.
• Strong interpersonal skills, with excellent written and verbal communication skills.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Director, Polysaccharide Development and Manufacturing
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.