Proteins Manufacturing Specialist

Vor 3 Tagen

Visp, Schweiz Vaxcyte Vollzeit

Vaxcyte's MSAT Team

We are seeking an experienced professional to join our Manufacturing Science and Technology (MSAT) team in the role of Proteins Associate Director. As a key member of our team, you will support microbial manufacturing operations from commercial readiness through process qualification and ongoing commercial production onsite at Contract Manufacturing Organization (CMO) service providers.

The primary responsibility of this role is to provide technical and operational support for manufacturing operations that ensure robust and efficient manufacturing processes. You will primarily be located in Visp, Switzerland.

This position will require the candidate to manage the complex microbial and connected cell extract and lysates manufacturing processes for Vaxcyte's vaccine portfolio. You will be responsible for developing and implementing processes and systems necessary for advanced MSAT capabilities at Vaxcyte.

About This Role

Vaxcyte is seeking an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Proteins Associate Director. In this position, you will be responsible for providing technical and operational support for manufacturing operations that ensure robust and efficient manufacturing processes.

You will work closely with various teams, including program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO/supplier management to ensure manufacture under GMP of different cell extract and lysates as well as carrier protein production required for Vaxcyte's vaccine portfolio.

This position will require the candidate to have strong experience in drug substance manufacturing under GMP regulations, understanding of quality systems, and experience in drug substance manufacturing equipment specification and qualification.

Main Responsibilities
  • Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns.
  • Build a Proteins MSAT team to support European CMO operations.
  • Enable MSAT proteins team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting.
  • Drive continuous improvement in manufacturing processes through technological innovation and application of first principles in process engineering.
Requirements
  • PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 7+ years of relevant Pharma/Biotech industry experience, or Master's degree in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 12+ 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, product recovery, and purification processes. Commercial manufacturing experience preferred.

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