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Associate Scientist/Scientist of Drug Product Engineering

Employer
Vaxcyte, Inc.
Location
Palo Alto, CA, United States
Start date
Jun 22, 2021

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Job Details

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of strain coverage, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; 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 by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds.

Summary:

Vaxcyte is looking for an energetic and talented individual to join the Formulation and 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 of the lead program. 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 (24) within the DP and the 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 Essential Activities:
• Generate early stage DP manufacturing processes that allow for accurate multivalent Drug Substance (DS) mixing, aseptic handling and homogeneity of the final suspension mixture prior to fill.
• 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
• Play a significant role in the build out of an in-house near full-scale production process for development and trouble shooting of the phase 3 process Vaxcyte, Inc., 353 Hatch Drive, Foster City, CA 94404
• Aid in oversight of the fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables
• In concert with the CMC team and external guidance, aid in late-stage process characterization and process validation
• Provide engineering support, in conjunction with the CMO to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of the 24 DSs
• Scaleup and validation of mixing solutions for the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill and facilitation of internal development work.
• Participate in cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs, in conjunction with other Regulatory/CMC leaders
• Aid in establishing supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems

Requirements:

• BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >4 year of industrial experience; or PhD with >2 years.
• Experience in early and/or late-stage clinical manufacturing within fill finish sites under GMP regulations
• Experience of chemical engineering in the biological manufacturing space, leading to custom engineering solutions
• Experience in the development of scaleup/down models and how they pertain to mixing of DP bulk, preferably suspension systems
• Experience in validation of DP processes, including the use of QbD as required
• 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

Reports to: Team Lead of Drug Product Engineering

Location: Palo Alto, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Company

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 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 by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.

Company info
Website
Phone
(650) 837-0111
Location
825 Industrial Road, Suite 300
San Carlos
CA
94070
US

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