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Vaxcyte
Vaxcyte
201 – 500 Angajați
Sponsor pentru viza H1BAsistență medicalăBiotehnologieIndustria prelucrătoare
Vaxcyte este o companie de biotehnologie specializată în vaccinuri, aflată în etapa clinică de dezvoltare, care creează vaccinuri împotriva infecțiilor bacteriene grave. Portofoliul său include candidații vaccinali conjugați cu spectru larg împotriva pneumococului VAX-31 și VAX-24, precum și programe aflate în stadii timpurii pentru streptococul de grup A și Shigella. Compania îmbină chimia sintetică cu o platformă de sinteză proteică fără celule, licențiată de la Sutro Biopharma, pentru a produce antigene proteice complexe. Activitatea de cercetare și dezvoltare se concentrează pe prevenirea bolilor invazive și pe combaterea consecințelor rezistenței la antibiotice, în special în rândul populațiilor vulnerabile.
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Locurile de muncă ale companiei

Director, Global Drug Substance Commercialization

Lead polysaccharide commercialization, launch readiness, and supply planning at Vaxcyte, a clinical-stage vaccine company. Coordinate technical, regulatory, manufacturing, and cross-functional delivery.

USStatele Unite ale Americii
223.000 $ – 261.000 $ / an
RemoteNormă întreagăLiderLimbă Obligatorie: englezăDirector

Descriere

  • Lead commercialization workstreams and prepare commercial supply of polysaccharides for glycoconjugate vaccines.
  • Plan and execute technical launch activities, including regulatory filings, facility readiness, and launch supplies.
  • Coordinate teams across Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering.
  • Turn commercialization strategy into execution plans and deliver key technical milestones.
  • Build technical capabilities and inform resource and staffing recommendations.
  • Strengthen process understanding and reliability by monitoring, trending, and optimizing operations.
  • Identify, communicate, and escalate technical and supply risks.
  • Oversee technology transfers, new technologies, internal and external manufacturing sites, and contract manufacturing organizations.
  • Lead process validation and comparability work.
  • Review and prepare regulatory filings, and respond to health authority questions.
  • Explain process performance and the scientific and commercial rationale for polysaccharide processes to internal and external stakeholders.
  • Lead assigned polysaccharide commercialization programs and technical workstreams.
  • Report to the Senior Director and Global Polysaccharide Commercialization Lead.
  • Travel 10–30%.

Cerințe

  • Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related field, with at least 10 years of relevant experience for a Ph.D., 12 years for an M.S./M.A., or 16 years for a B.S./B.A.
  • Extensive experience with biologic production processes, including bacterial fermentation, recovery, and purification at multiple operating scales.
  • Experience with polysaccharides and glycoconjugate vaccines is highly preferred.
  • Leadership experience in MSAT or Process Development, in supervisory and/or matrixed team roles.
  • Apply deep technical knowledge collaboratively to shape strategic plans and achieve shared goals.
  • Strong organization, problem-solving, and strategic planning skills.
  • Excellent verbal and written communication, including the ability to work effectively with people from diverse backgrounds and perspectives.
  • Recognize needs and challenges and put effective solutions in place.
  • Find and analyze data from varied sources to support decisions and align others with organizational strategy.
  • Bring an entrepreneurial, creative approach to developing new ideas.
  • Able to travel 10–30%.

Beneficii

  • Comprehensive benefits package.
  • Equity component.

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USStatele Unite ale AmericiiPAPennsylvania
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