Process Development Lead, Biosample Managememt ( PCV )

Genentech   •  

San Francisco, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 175 days ago

This job is no longer available.

Responsibilities

  • 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

?Qualifications

 

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

Job ID: 3600091824