Offers “Roche”

Expires soon Roche

Principal Scientist II - Sequencing

  • Internship
  • Pleasanton (Alameda)

Job description



·  Job facts

SUMMARY

The Principal Scientist II will be part of the Assay development team in Pleasanton within the Roche Sequence Solutions business, focusing on IVD NGS Assay development for Oncology. We are looking for a motivated and team-oriented individual who is passionate about creating innovative diagnostic solutions to address unmet medical needs for cancer care. The successful candidate will be responsible for driving new product introduction to completion by leading the team through feasibility, verification and validation phases of product development. The ideal candidate should have extensive experience developing and validating assays in IVD-regulated environments, including successful interactions with the FDA.

RESPONSIBILITIES

·  Designs and leads advanced independent studies from feasibility through, verification and validation. Assumes responsibility for timely completion of studies, ensuring activities are consistent with project critical path and responding appropriately to changing priorities.
·  Drives study documentation in compliance with good laboratory practices & quality systems requirements to support regulatory filings. Presents findings or comprehensive project status reviews at internal seminars/meetings. Prepares summaries, internal reports, presentations, manuscripts, etc.
·  Works on complex problems requiring significant analysis and evaluation of intangible variables; may refer to established precedents and policies.
·  Participates in project planning, process updates, study design and critical decision making, works closely with other departments (e.g., Bioinformatics, Systems, Operations, Quality, Marketing, Regulatory Affairs, and Clinical Science etc.) to further project goals.
·  Positions with people management responsibility have full HR responsibility for direct and indirect reports that includes hiring/firing recommendations, interviewing, selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints.
·  Participates in external collaborations and product/technology transfers by providing scientific knowledge and assistance. 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.

REQUIREMENTS

·  Ph.D. in Molecular biology, Biochemistry, or related fields with 7+ years of relevant industry experience, or B.S/M.S.in similar disciplines with 10+ years of relevant industry experience.
·  Strong background in molecular biology and expertise in assay optimization, experimental design, and versatile laboratory practice is required. Hands-on experience with clinical samples and automation is preferred.
·  Strong data analysis and interpretation skill is required. Expertise in next-generation sequencing based workflows including library prep, target enrichment and data analysis is preferred.
·  A proven track record of leading IVD or RUO assay development is required. Familiar with quality assurance systems and in vitro diagnostic regulations such as CE-IVD(R), CLIA, and FDA US-IVD is preferred.
·  Hands-on, practical knowledge of requirements of working under design control is required.
·  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 in a fast paced and dynamic environment.

Roche is an equal opportunity employer.
Research & Development, Research & Development > Research

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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