Process Development Lead, Biosample Managememt (PCV)

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 global partners. PCV is an RNA-based cancer vaccine targeting neoantigens manufactured on a per-patient basis. 


We are seeking a highly motivated Development Scientist to develop sample preparation methods for the Personalized Cancer Vaccine project. The incumbent will work closely with collaborators to understand, improve and implement protocols to collect and prepare samples for use in the Personalized Cancer Vaccine process.  She/he will participate in cross functional teams and support the program by ensuring consistent, reliable preparation of samples.  A particular focus for this position will be to establish and develop a strong collaborative relationship with teams at clinical sites who collect and prepare samples. The successful candidate is expected to serve as a single point of contact for questions related to manufacturing samples. Effectively communicating to and develop collaborative relationships with key investigators and opinion leaders will be an essential part of the assignment.



  • Maintain oversight over the status and quality of all study samples, track and regularly report on trends
  • Collaborate with the broader Personalized Cancer Vaccine team to evaluate and develop biosample preparation methods and associated criteria
  • Initiate and grow connections to key stakeholders at clinical surgical centers including interventional radiologists, pathologists and lab directors to better understand their needs and workflows
  • Use investigator meetings as a forum to drive optimization of PCV manufacturing sample collection
  • Develop and provide support to ensure that key staff at all clinical sites are uniformly trained and aware of Personalized Cancer Vaccine sample requirements and apply best practices to their preparation
  • Maintain professional knowledge of current GCP and sample management policies, best practices and ethical guideline



The ideal candidate will meet the following qualifications:

  • Advanced degree in a scientific or medical discipline
  • Minimum 5 years of experience in clinical biosample workflows in research setting.  Specific experience with clinical oncology samples and is desirable
  • Demonstrated understanding of pharmaceutical regulatory requirements, both US and abroad
  • Demonstrated knowledge of ICH and GCP guidelines
  • Effective team player and ability to collaborate with cross functional teams
  • Ability to oversee sample management activities across multiple clinical sites
  • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
  • Excellent written and communication skills
  • Proficient with sample data reporting, managing metrics and understanding the overall quality and stability of study samples
  • Proven critical reasoning skills including the identification and resolution of complex problems
  • Able to travel at up to 20%

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.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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