CIR Senior Scientist – Bioinformatics

Job Description:
We are looking for a highly motivated Senior Bioinformatics Scientist to join our Roche Sequencing Solutions team to support our next generation sequencing (NGS) product portfolio. The department ‘Case Investigation and Resolution’ is the Center of Excellence for the resolution of global product issues and monitors effective resolution of global and local cases ensuring optimal levels of customer satisfaction and regulatory compliance.

Within Case Monitoring and Resolution (CMR), the Case Investigation & Resolution (CIR) Senior Scientist is accountable for the following key responsibilities:

Essential Job Functions and Major Contributions:

• Assumes management of individual cases (Inquiries, Complaints, PRI/PSIs) according to regulatory and ISO Quality system requirements and the needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site troubleshooting and resolution of cases, in a timely manner. Cases need to be auditable and well documented to be self-explanatory to a person who has no specialized product or process knowledge (e.g. in an audit).
• Is responsible for experimental design of investigations of complaints to ensure an efficient approach for root cause analysis. Performs/assists in complex investigations by proactively identifying and collaborating with appropriate functions to identify root causes, plausible factors workarounds.
• Scientific documentation of investigations. Where appropriate including (but not limited to) test plan, proof of statistical relevance, documentation of methodology, conclusion and traceability of an investigation.
• Assumes responsibility to ensure, by collaborating and interfacing with the BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds.
• Initiates, monitors and ensures completion of complaint CAPAs and triggers appropriate preventive actions resulting from cases.
• Initiates and monitors the implementation of product documentation updates, modifications and developments resulting from cases, influencing the future of products in the field.
• Assumes responsibility for timely communication of quality related information to the Country Organizations. Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
• Assumes responsibility for regular review of escalated cases. Contributes to constant evaluation of global case resolution vs. regional and local practice.
• Is responsible for initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge.
• Provides regulatory inspection support.
• Contributes to creation of regular reports to document in-market product quality and performance, to escalate critical issues to the responsible LCT and to define pro-active measures.
• Contributes to case-related trending to understand scope of an issue.
• Performs regular review of quality of case handling, CAPA management and analyzes feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.
• Assumes accountability for mentoring new employees and team members.

Other Tasks, Duties and Responsibilities:

• Creates “notifications” (Bulletins and communications to affiliates and ultimately customers via the local organizations) and contributes to creation of reports (any type of trending or KPI reporting, on product or process performance) generally used by the department to report progress or to be presented to interfacing areas (e.g. BA, LCTs, IBT, Global functions).
• Could contribute in task forces for individual case/issue in their area of competency, including representation and communication of individual case/issue results in interfacing meetings. May be required to lead task force.
• Analysis and completion of risk assessments resulting from differing failure modes.
• Performs / assists in on-boarding of new employees.
• Could act as proxy for Principals (empowered to take decisions).
• Permanently optimize processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement, by supporting regular review of quality of case handling, CAPA management and by analyzing feedback on customer satisfaction.

Qualifications:

• University degree in Life Sciences (molecular biology, genomics, genetics, sequencing, biology, medical technology or similar) and related bioinformatics technical experience or equivalent professional experience is required.
• Sound technical knowledge of next-generation sequencing, genomics, non-invasive prenatal testing, molecular biology, or related technologies and applications. Product knowledge and principle of operation for the product’s intended use, customer workflow and technical knowledge of assay and system functionality is required.
• Several years (>2 years) of work experience in either 1st or 2nd level product support, in the area of Medical Devices/ IVD products or R&D/QC related functions.
• Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g. 21CFR 820,198, ISO 9001, ISO 13485, etc.). Complaint handling experience desirable.
• Proven strong interpersonal skills with an analytical, solutions oriented, collaborative approach to problem solving.

Other Qualifications & Competencies:

• Several years of analysis experience with short read NGS data, including standard pipelines (eg. bwa, samtools, GATK, Varscan etc.), variant detection algorithms, variant annotation and QC metrics.
• Proficiency in a high level scripting language (e.g. Python, R, Perl) required.
• Strong communication skills in English (written and spoken) are essential. Knowledge of additional languages is a plus.
• Detailed, technical orientation with excellent analytical and organization skills, strong problem solving, troubleshooting capabilities and negotiation attitude.
• Ability to draw conclusions on individual cases independently and to provide guidance to others.
• Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).
• Computer literate, knowledge of e-learning and multimedia technologies.
• Very good presentation and communication skills. Experience in technical writing.
• Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner.
• Knowledge of the diagnostic market.
• Intercultural skills.
• Strong customer focus and business orientation.
• Travel requirements of approximately up to 25%.

Who you are:

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

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Requeriments :

• Technical Bachelor

Skills :

• genomic
• molecular biology
• Next Generation Sequencing
• Programing in Python
• Programming in PERL
• Programming in R

Areas :

• Bioinformatics

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Additional Info:
At Roche, 94,000 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.

Research & Development, Research & Development > ResearchPleasanton

Who we are:

At Roche, 94,000 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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