Senior Process Development Associate, Bioinformatics (iNeST)
South San Francisco, CA

Job Description

This position is part of the Individualized Neoantigen Specific Therapy (iNesT) team responsible for the process development, manufacture and supply of personalized immunotherapies in collaboration with our global partners. iNeST is an RNA-based molecule that targets neoantigens and is manufactured on a per-patient basis.

We are seeking a highly motivated team member to contribute to the ongoing effort to operationalize bioinformatics aspects of iNeST manufacturing. You will conduct bioinformatics analysis to support ongoing process development, refinement of the iNeST analysis pipeline and clinical manufacturing operations. You will represent the iNeST team at cross-functional team meetings. The successful candidate is expected to effectively communicate and develop collaborative relationships with key stakeholders. Once a strategic framework for future manufacturing is in place, you will play a critical role in implementation to enable commercial iNeST manufacturing.

Responsibilities

* Provide the strategic and operational support needed for bioinformatics functions within Genentech's iNeST program.


* You will play a critical role in enabling a new manufacturing paradigm for Roche/Genentech that includes next-generation sequencing and advanced bioinformatics techniques to deliver individualized immunotherapeutics to patients.


* You will be expected to provide guidance and feedback on iNeST development programs to internal and joint management teams. Ensure alignment of genomics/bioinformatics milestones with those of the broader team. Serve as the single point of contact to key stakeholders to execute on jointly defined deliverables, from project kick-off to method implementation.


* You will be a key contributor to production scale deployment and software engineering/QA aspects of the iNeST bioinformatics pipeline.



Qualifications:

The ideal candidate will meet the following qualifications:

* Ph.D or MS in bioinformatics or a related discipline. 2-3 years minimum industry experience in bioinformatics analysis with emphasis on oncology


* Expertise coding in Python, R or Matlab


* Strong understanding of software engineering/quality assurance and workflow management is a requirement


* Previous experience and strong understanding of production bioinformatics workflows


* Must be detail-oriented with excellent organizational skills in order to manage multiple projects and meet assigned deliverables


* Strategic agility and ability to adapt to the evolving personalized healthcare environment


* Ability to work well on teams and keep relevant stakeholders informed regarding the status of programs


* Strong written and verbal communication skills and ability to effectively communicate with cross-functional teams


* Understanding of oncology drug development process is preferred


* Working with deployment to cloud environments using Docker or similar containerization packages is a plus


* Familiarity with regulatory standards (ISO 13485, IEC 62304, etc) is desirable


* Comfortable working in a flexible, fast-paced team environment



Business travel up to 20-30% is anticipated for this role

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Roche is an equal opportunity employer.

Manufacturing, Manufacturing > Operational Excellence