Engineer II, Drug Product Engineering

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:
 
Vaxcyte is looking for an energetic and talented individual to join the Drug Product Development (DP) team. The primary responsibilities for the incumbent will be to support the DP process development of pre-clinical programs through to the phase 3 and commercial readiness. This position will require the candidate to develop scalable and scaled manufacturing process for Vaxcyte’s vaccine portfolio, being highly complex biological products.
 
Due to the high number Drug Substances within the DP and a suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. The candidate will need to relish the scope and size of this unique challenge.  In addition, our pre-clinical vaccine program, VAX-A1, is moving into a period of high intensity focus in preparation for GLP and GMP work.
Essential Functions:

• Develop early-stage DP manufacturing processes including aspects relating to scale-down model development, characterization, and scale-up of unit operations for parenteral manufacturing (i.e. filling, filtration, mixing, etc.).
• Enable the team in general process design, including contact material selection, hardware design/construction, filter selection/sizing, mixing and filling activities at the phase 1 scale and in down scaled models.
• Aid in oversight of the fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables and fill/finish process development.
• In concert with the CMC team and external guidance, aid in late-stage process characterization and process validation.
• Lead all aspects of and engage in the planning, design, execution, and documentation of DP fill/finish process development studies.
• Collaborate with the DP Formulation Team to troubleshoot and optimize the DP as required for phase 1, 2, 3 and commercial needs.
• Drive continuous improvement in DP development process through technological innovation and application of first principles in process engineering.
• Participate in process development activities for commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and ongoing commercial manufacturing.
• Apply statistical/data analytics techniques to draw conclusions and make informed decisions.

Requirements:

• Bachelor’s degree and >6 years of scientific/process development experience OR Master’s degree and >4 years of scientific/process development experience. BSc or MSc in Chemical Engineering, Pharmaceutical Sciences, the physical sciences, or a related field preferred.
• Experience in clinical/commercial manufacturing within fill finish sites and understanding of Quality systems and Drug Product Manufacturing under GMP regulations preferred.
• Apply knowledge of pharmaceutical science and engineering to overcome challenges around drug product manufacturing and scale up.
• Experience in the development of scaleup/down models for DS or DP processes
• Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats.
• Ability to work within in a fast-paced, cross functional environment, multitasking as needed.
• Ability to independently design and implement drug product process development and characterization experiments while adhering to scientifically-sound practices, including the design, execution, review, and interpretation of experiments.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Senior Engineer, Drug Product Engineering
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $118,000 - $139,000