Director, Microbial MSAT
San Carlos, CA, USA
Posted on Thursday, November 2, 2023
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.
Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Director Microbial Manufacturing. The incumbent will support the microbial manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at CMO service providers, with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Visp, Switzerland, but will have responsibilities to oversee CMOs in Italy and Germany as well.
This position will require the candidate to manage the highly complex microbial manufacturing processes for Vaxcyte’s vaccine portfolio. This role will be responsible for developing the organization and implementing the processes and systems necessary for advanced MSAT capabilities at Vaxcyte.
This is an exciting opportunity to join an outstanding team, with a mission to establish an onsite MSAT group supporting late-stage clinical manufacture, launch, and commercial operations. The successful candidate will have the following skills and qualities:
·A skilled scientist or process engineer with expertise in microbial fermentation, product recovery, and purification
·A strong technical leader experienced in providing mentoring and training for staff members.
·An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.
·The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders.
·A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind.
- Work cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of different protein-polysaccharide conjugate Drug Substances required for Vaxcyte’s vaccine portfolio.
- Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns.
- Build a Microbial MSAT team to support European CMO operations.
- Enable Microbial MSAT team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting.
- Lead all aspects of and engage in the planning, design, execution, and documentation of DS manufacturing process Investigations and CAPAs.
- Drive continuous improvement in manufacturing processes through technological innovation and application of first principles in process engineering.
- Support the process to select new CMOs and suppliers.
- Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies.
- Recommend and implement new technology that advances knowledge and productivity within the department.
- Author and review technical reports, manufacturing documents, regulatory submissions, and publications.
- Present at department, project team, and senior management meetings. May present externally at scientific conferences.
- PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 10+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 15+ years of relevant Pharma/Biotech industry experience.
- Experience with Vaccine manufacturing operations preferred.
- Strong experience in Drug Substance Manufacturing under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance manufacturing equipment specification and qualification preferred.
- Strong scientific or technological (process engineering) background and hands-on experience with biochemical reaction OR bacterial fermentation, product recovery, and purification processes. Commercial manufacturing experience preferred.
- Deep knowledge of protein-polysaccharide conjugation principles; OR In-depth understanding of bacterial fermentation principles, bioreactor systems and process analytics/control systems
- Sound knowledge of:
- product recovery unit operations such as homogenization/ microfluidization, centrifugation, and depth filtration
- product purification unit operations such as chromatography, UF/DF TFF, and precipitation
- process analytics/control systems
- Experience with cell-free upstream technology a plus but not required.
- Strong ability in troubleshooting equipment/technology and process. Adept at FMEA. Excellent analytic skills. Experience in Investigations and development and implementation of CAPAs preferred.
- Experience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired.
- Strong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats. Experience with Cross-Functional teams and managing direct reports.
- Proven technical leadership skills including strong project management skills.
- Fluency in spoken and written English is mandatory.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Senior Vice President, Commercial Manufacturing & Supply Chain
Location: Visp, Switzerland
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $211,000 – $224,000
Send resumes to:
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.