Principal Scientist I

The Principal Scientist I will be part of Assay development team in Pleasanton within the Roche Sequence Solutions business, focusing on the optimization and early development of oncology assays and applications for use on next-generation sequencing platforms. We are looking for a motivated and team-oriented individual who is passionate about finding new ways to win the war on cancer by revolutionizing cancer diagnosis. The successful candidate will design, lead and execute advanced independent studies to support the early development of assays and to assess interesting clinical questions, defining study goals and analysis plans and applying advanced scientific knowledge to complete projects. 

ESSENTIAL FUNCTIONS:

• Designs and leads studies to test hypotheses related to project outcomes. Analyzes data, evaluates results, forms conclusions, and determines future experiments.

• Recommends innovative approaches, and/or expansion or curtailment of investigations based on experimental data or new scientific information arising from area of responsibility. When appropriate, acts independently to resolve scientific problems encountered during experimental procedures to improve productivity of results. 

• Presents findings or comprehensive project status reviews at internal or external seminars/meetings.  Applies advanced technical writing skills to produce manuscrips, and reports.  Prepares internal reports, presentations, manuscripts, posters, etc.

• Participates in project planning, process updates, study design and critical decision making. Assumes responsibility for timely completion of studies, ensuring activities are consistent with project critical path and responding appropriately to changing priorities.

• Works closely with other departments (e.g., Bioinformatics, Medical and Scientific Affairs, Commercial, Marketing, Manufacturing/Operations, Global Customer Support, Quality, Regulatory Affairs) to align and to further project goals.

• May work with external academic or pharma collaborators to identify potential clinical studies, define study goals, communicate study progress, and present final study analyses and results.

• Participates in the expeditious transfer and optimization of products and technologies by providing scientific knowledge and assistance.

• Consistently provides expert-level technical expertise related to Next Generation Sequencing and its application to oncology, both within development and cross=-functionally.  Provides technical advice/guidance to junior scientific staff, and serves as a role model.

• Ensures technical activities under delegated supervision are conducted within internal and external guidelines and regulations. 

• May have people management responsibility for direct and indirect reports which includes hiring/firing decisions, interviewing, selections, performance feedback, discipline, pay decisions and handling employee grievances/complaints.

MINIMUM REQUIREMENTS:

• Ph.D. in Molecular biology, Biochemistry, or related fields with 0+ years of relevant industry experience, or B.S/M.S.in similar disciplines with 7+ years of relevant industry experience.

• Strong background in molecular biology and expertise in assay optimization, experimental design, and versatile laboratory practice is a must. Hands-on experience with clinical samples and automation is a plus.

• Expertise in next-generation sequencing based workflows including library prep, target enrichment and data analysis.  Strong data analysis and interpretation skill is a must.

• Familiarity with command line and some experience in at least one high-level coding language (e.g. R, perl, python) is a must.  Knowledge of bioinformatic algorithms is a plus.

• Assay development experience is highly preferred. Familiar with quality assurance systems and in vitro diagnostic regulations such as CE-IVD, CLIA, and FDA US-IVD is a plus.

• Strong background in oncology is preferred.

• Team oriented with excellent interpersonal skills and ability to take ownership and accountability of assignment.

• Excellent written and oral communication skills and ability to effectively communicate with cross-functional teams.