Sr. Associate Engineer, Pilot Plant

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 (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-XP, a PCV with coverage of 31 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 150 employees and anticipates continued, significant growth. Following the October 2022 follow-on equity offering, which generated approximately $651 million in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. On October 24, 2022, the Company announced positive topline safety, tolerability and immunogenicity data from the Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64. 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-XP, 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:
 
Vaxcyte is looking for an energetic and talented Sr. Associate Engineer to contribute to the Polysaccharide Upstream Pilot Plant function within the CMC team. Vaxcyte is developing a multi-valent polysaccharide-based conjugate vaccine, based on a novel carrier protein produced using the Xpress CF platform. Polysaccharides are a critical component in conjugate vaccines.
 
The successful candidate will have practical laboratory fermentation experience in executing, supporting, or developing upstream processes related to biotechnology, biopharmaceuticals, or vaccine industries. The candidate will be eager to utilize and learn new laboratory skills as this person will be responsible for collaboration on experimental design and execution of experiments at pilot scale for scale down modelling efforts and manufacturing program development. This position will require >50% time in the lab and this person will be able to independently detail experimental procedures/results in written and presentation formats. The successful candidate will write detailed technical reports, present experimental results internally, and potentially interface with external CMO partners.
Essential Functions:

• Operate and maintain equipment and instrumentation for polysaccharide fermentation such as fermenters, centrifuges, depth filtration, TFF systems and metabolite analyzers.
• Perform analysis and interpret results for polysaccharide and impurity assays (Anthrone, Lowry).
• Assists in design and execution of upstream process characterization studies.
• Work with Polysaccharide team to develop plans for upstream development and material generation needs for scale down model development.
• Keep accurate and current records of development experiments and/or project related activities in laboratory notebooks or electronic laboratory notebook.
• Review executed protocols and batch records from Manufacturing.
• Present/communicate data to polysaccharide team.
• Contribute to technical discussions within the polysaccharide team.
• Writes, reviews, and approves protocols, batch records, and reports in support of process development.
• Works within a team environment and provides support as necessary to further the team’s initiatives.

Requirements:

• Senior Associate Engineer: BS in Chemical Engineering, Biochemistry, or a related discipline, with 5+ years of industry experience; MS with 3+ years of industry experience.
• Practical experience in supporting/executing bioprocess operations and/or strong understanding of traditional processing unit operations including fermentation, depth/micro-filtration, and centrifugation.
• Familiarity with DoE (Design of Experiments) principles; practical experience with DoE software a plus.
•    Process characterization experience is a plus.
• Demonstrated understanding/proficiency with engineering principles involved in scaling processes (lab, pilot, manufacturing).
• Proficient with computer programs such as Microsoft Excel, Word, PowerPoint, Visio and JMP.
•    Experience with process modelling software a plus.
• Working knowledge of the requirements of GMPs.
• 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: Associate Director, Polysaccharide Pilot Plant and Manufacturing
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $107,000 - $117,000