Process Development Lead, Drug Product - PCV (SSF)

South San Francisco
California, United States of America


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The Position

This position is part of the Pharma Technical-Personalized Cancer Vaccine (PT-PCV) team responsible for the process development, manufacture and supply of personalized cancer vaccines (PCVs) in collaboration with our partner BioNTech.  PCV is an RNA-based cancer vaccine targeting neoantigens manufactured on a per-patient basis.  A lipoplex nanoparticle formulation for the RNA (RNA-lipoplex) is used to enable intravenous delivery.

The scope of the Drug Product Lead role spans early and late stage pharmaceutical development activities for the PCV program. The Drug Product Lead will collaborate with BioNTech and internal partners to:   

  • Support formulation development activities for ongoing clinical trials and commercialization.  The Drug Product Lead will be responsible for guiding the design and execution of stability and PC/PV studies in collaboration with BioNTech.
  • Support the development of clinical administration procedures.
  • Support the design of drug product processing equipment for the manufacture of RNA-lipoplex nanoparticles and selection of drug product filling equipment for the commercial process.
  • Support the process transfer of drug product manufacturing unit operations to commercial manufacturing site(s).
  • Author and review technical reports, process validation documents, and portions of regulatory submissions to support ongoing clinical trials and licensure. 

Qualifications

  • BS/MS/PhD in Biochemistry, Biology, Chemical Engineering, Bioengineering or Pharmaceutical Technology or related discipline.
  • Approximately 10 years of cross-functional pharmaceutical development experience in drug product process development and/or manufacturing support with practical knowledge of fill/finish manufacturing processes. 
  • Strong background in the relevant unit operations including mixing, formulation, sterile filtration, sterilization, aseptic processing, component processing technologies, filling, and visual inspection.
  • Prior experience with GMP fill-finish equipment, technology transfers, process validation and risk assessments is highly desired.
  • Development and manufacturing experience related to primary packaging components is highly desired.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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