Associate Director, MSAT Proteins
Vor 6 Tagen
Vaxcyte: Protecting Humankind
We are a clinical-stage vaccine innovation company that develops high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella.
Job OverviewVaxcyte is seeking an experienced professional to join our Manufacturing Science and Technology (MSAT) team in the role of Proteins Associate Director. In this position, you will support microbial manufacturing operations from commercial readiness through process qualification and ongoing commercial production onsite at Contract Manufacturing Organization (CMO) service providers.
You will be responsible for managing the complex microbial and connected cell extract and lysates manufacturing processes for Vaxcyte's vaccine portfolio. Additionally, you will develop and implement processes and systems necessary for advanced MSAT capabilities at Vaxcyte.
Main Responsibilities- 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 cell extract and lysates as well as carrier protein production 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 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.
- 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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