Manufacturing Biosample Manager, iNeST

United States of America, California, South San Francisco

de fr es ru tr it pt zh ja

We are seeking a highly motivated individual to support the operational aspects of tissue collection and processing for the individualized neoantigen specific therapy (iNeST)program at Genentech. The incumbent will work closely with clinical operations and supply chain teams to ensure manufacturing teams obtain tumor and blood samples in a reliable, timely manner.  She/he will represent the iNeST team in cross functional teams and support efforts to collect and analyze process metrics.  The successful candidate is expected to serve as a single point of contact for questions related to the status of manufacturing samples. Effectively communicating with stakeholders within and outside Roche/Genentech is a key requirement for this role.  

 

Responsibilities

  •  Maintain oversight over the status and quality of all study samples in real time, track and regularly report on trends

  • Responsible for overall strategy for manufacturing biosample collection 

  • Collaborates with clinical operations and supply chain teams to resolve issues and ensure manufacturing samples are obtained in a timely manner

  • Works directly with external counterparts to understand and improve the iNeST manufacturing process

  • Acts as manufacturing single point of contact for evaluating changes to clinical protocol and laboratory instructions, and ensures that manufacturing procedures comply

  •  Maintain professional knowledge of current GCP and sample management policies, best practices and ethical guidelines


Qualifications

 

The ideal candidate will meet the following qualifications:

  • Advanced degree in a scientific or medical discipline

  • Excellent written and communication skills 

  • Minimum 8+ years of experience in clinical biosample workflows, well versed in sample handling and processing in an industry setting.  Specific experience with clinical oncology samples 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

  • 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%

#ptcareers

#ptd

Roche is an equal opportunity employer.

Research & Development, Research & Development > Clinical Operations