Biologics MS&T Process Scientist & Tech Transfer Lead

AstraZeneca

Frederick (MD)

Presencial

USD 112.000 - 168.000

Jornada completa

Hace 3 días
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Ventajas ofrecidas por este puesto de trabajo

401(k) plan
Health benefits
Paid vacation

Descripción de la vacante

AstraZeneca plc in Frederick Manufacturing Center seeks a MS&T Process Scientist to lead technology transfer and production support for clinical and commercial biologics. You will manage TT activities, oversee batch reviews, and mentor junior staff on the manufacturing floor, ensuring robust process development and risk mitigation.

The role requires deep CMC understanding, GMP compliance, and strong data interpretation skills to drive drug substance projects from lab to production.

Formación

  • BS/BA/MS/PhD in Engineering, Biological/Physical Sciences or related field.
  • 7+ years in cGMP biopharmaceutical production or process development.
  • Experience with biologics manufacturing and tech transfer.

Responsabilidades

  • Lead TT and production support activities including fit-to-plant and batch record review.
  • Serve as Drug Substance process Workstream Lead for clinical and commercial projects.
  • Mentor colleagues and supervise entry-level scientists.
  • Understand CMC activities related to TT.
  • Analyze data using MVDA software and present results.
  • Prepare technical reports and deliver presentations.

Conocimientos

Upstream/Downstream TT experience
Biologics experience
Cell culture
GMP knowledge
Critical thinking
Strong communication

Educación

BS/BA/MS/PhD in Engineering or Biological/Physical Sciences

Herramientas

MVDA software

Descripción del empleo

AstraZeneca plc in Frederick Manufacturing Center seeks a MS&T Process Scientist to lead technology transfer and production support for clinical and commercial biologics. You will manage TT activities, oversee batch reviews, and mentor junior staff on the manufacturing floor, ensuring robust process development and risk mitigation.

The role requires deep CMC understanding, GMP compliance, and strong data interpretation skills to drive drug substance projects from lab to production.

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