The Position
Acts as an escalation point for non-routine product complaints. Develops and updates company complaint and inspection procedures to ensure capture and investigation of complaints. Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development. Documents and tracks contact information, reported issues and problems in accordance with company guidelines and external regulatory requirements. May collaborate with other internal groups to respond to product inquiries and issues.
Main tasks:
* Accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations, including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases.
* Resolve cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects.
* Assume responsibility to ensure, by collaborating and interfacing with the BA and global and/or local functions, appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.
* Assume responsibility for ensuring risk assessments for product quality issues are complete.
* Participate in the on-boarding and mentoring activities of new employees and team members, as assigned.
* In Case Handling and Affiliate Support (CHAS) - Interface with Affiliates, assuming responsibility for timely communication of quality related information to the Country Organizations. Support initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
* In Complaint Investigation and Resolution (CIR) - Responsible for experimental design of complaint investigations, conducts investigation experiments. Partner with internal Roche Global Functions (i.e. Operations, Research and Development, CDMA).
* Analyze data using statistical measures for determining a potential product performance issue.
* Responsible for escalating cases which cannot be directly resolved to appropriate levels and initiating further investigation / communicating case derived information as appropriate.
* Assume responsibility for timely communication of quality related information to the Country Organizations.
* Proficiency in English (B-level), expressed communication skills and intercultural competence.
* Ensure cases are compliant and conform to established quality processes, standards, and regulations.
* Support product teams by providing information from cases in order to update product documentation.
* Contribute to 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.
* Create "notifications" (bulletins and communications to affiliates and, ultimately, customers via the local organizations), and approve notifications received.
* In RIS&SSW: May browse the code repository and consult source code files when required to ensure a correct investigation but never making any modifications in the repository or the checked-in source code.
* Work autonomously, with minimal supervision.
* Ensure efficient laboratory organization and ensure compliance with laboratory policies.
* Ensure inspections of the responsible laboratory equipment and test equipment are done, including complete documentation.
Additional tasks:
* May provide audit and inspection support as requested.
* May contribute to the creation of regular reports to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define proactive measures.
* May support regular review of quality of case handling and analyze feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with a focus on customer, compliance and continuous improvement.
* May initiate complaint CAPAs and/or nonconformities and perform any assigned CAPA tasks.
* May represent the PMQ on key cross-team meetings and projects.
* May act as a coach for colleagues with less experience and provides guidance and feedback to other case owners on the case handling processes and product technical knowledge.
* May lead or contribute with skills to projects e.g. Squads/Communities of Practice.
* May act as a proxy for the Principal role.
* The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. May be required to perform other duties as assigned to meet the PMQ goals and objectives, as appropriate.
For all employees:
* Permanently optimizes processes in order to increase quality and efficiency standards.
Years of Experience:
* 3-5 years of experience in Histology and/or Pathology Laboratory preferred
* 3-5 years of experience in Primary Staining, Special Staining, Immunohistochemistry, and In-situ Hybridization preferred
* 3-5 years of experience with Q/A and Q/C specifically in the Histology/Pathology Laboratory preferred
* 3-5 years of experience with Customer Support, field technical support, and face to face customer support and training. Related core laboratory field technical support may also be considered.
* Proficiency in technical writing is required.
Preferred Knowledge, Skills and Abilities
* Demonstrate solid critical thinking and problem solving skills.
* Demonstrate solid understanding of Immunohistochemistry and In-Situ Hybridization techniques.
* Demonstrate good understanding of Roche Pathology Lab Primary Antibodies and Detection Chemistries.
* Demonstrate good understanding of Immunology and its relationship with IHC and ISH.
* Demonstrate good laboratory practices.
* Collaborative team member with positive attitude.
* Demonstrate good communication skills: verbal, writing, presentation, technical writing a plus.
* Good investigation techniques. (Able to develop and execute a precise Design of Experiment)
* Able to perform IHC and ISH testing. Both manual and automated.
* Troubleshooting skills.
Education
* Bachelors in life sciences, pathology, engineering or related field required.
* Advanced degree in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics or related sciences is preferred.
Relocation assistance is not available for this position.
Who we are
At Roche, more than 100,000 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.
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.
Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.
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.
If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.$90k-126k yearly est.2d ago
Sr. Principal Scientist - Translational Medicine Digital Pathology
The expected salary range for this position based on the primary location of South San Francisco, CA is $169,800-315,300.$169.8k-315.3k yearly20d ago
Senior Principal Bioinformatics Scientist, NGS Algorithms
* The expected salary range for this position based on the primary location of Pleasanton CA is $142,100 - $263,900.$142.1k-263.9k yearly30d ago
Scientist - Synthetic Organic Chemistry
The Position
Responsibilities
Conceives, plans, designs and conducts advanced independent research in the areas of organic synthesis; specifically dyes, phosphoramidites, and oligonucleotides. The focus will be on production of rare reagents needed for development of new immunohistochemical assays for tissue diagnostics. Additional responsibilities will include supporting the Pathology Chemistry and Integrated Analytics department with formulation science, chemical and material compatibility, analytical reagent characterization, product quality investigations, and bioconjugation chemistry.
Multi-step synthesis expertise at gram scale with related purification and characterization experience.
Manages reagent project demands with technical and business colleagues to deliver on time and within budget.
Makes significant contributions to all areas that need chemistry expertise, such as material compatibility, reagent stability, formulations and raw material specifications.
Utilizes analytical chemistry knowledge to support assay development based on new and existing methodologies, developing, verifying, and validating testing methodology used to control raw materials, production intermediates, and final products.
Experience with multiple gram-scale purification and analytical characterization techniques, such as preparative and analytical UPLC, mass spectrometry (MS), flash and thin-layer chromatography, NMR, FTIR, UV-Visible and fluorescence spectroscopy.
Utilizes new or existing methods for identifying and determining the structure of novel compounds or bioconjugates, including validation and documentation for analysis and evaluation of material and products at all stages of the development process.
Performs testing of analytical samples for the laboratory area, including the separation and characterization of candidate compounds, formulations development, peptide synthesis, protein modification, nucleic acid synthesis.
Knowledge of bioanalytical techniques related to chemically-modified proteins, such as dye-, hapten- and enzyme-antibody bioconjugates.
Receives general direction and exercises discretion as to work details.
Contributes to the definition and timely achievement of overall project goals.
Participates or leads in efforts to define new components, products or processes.
Identifies, trouble-shoots and solves technical challenges.
Creates potentially patentable components for systems, reagents or processes.
Designs and executes experiments to test hypotheses related to project outcomes.
Applies advanced scientific knowledge to projects; determines priorities for experiments.
Participates on cross-functional technical teams, such as a failure investigation or project team.
Establishes interfaces across other organizational groups.
Provides technical direction and feedback to others.
Participates in project planning, process updates and contributes to experimental design.
Prepares and delivers presentations of project results to others; presents data to larger and more diverse audiences.
Monitors work to ensure quality, and continuously promote Quality First Time.
Other duties as assigned by management
Formal Training/Education
Education Level
Bachelor's Degree in Science Required.
Master's Degree in Science Preferred.
Ph.D. in Science in Science Preferred.
If degree is in a non-scientific field, Executive Committee approval in required.
Experience
Years of Experience
8 years with Bachelors Degree Required.
3 years with Masters Degree Required.
Entry level with Ph.D Required.
Who we are
At Roche, more than 100,000 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.
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.
Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.
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.
If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.$85k-115k yearly est.1d ago
Principal Scientist I Bioinformatics
The Position
Roche Sequencing Solutions (RSS), a business within Roche Diagnostics, focused on developing a disruptive Next-Generation Sequencing (NGS) platform along with a portfolio of reagents, assays and informatics solutions for multiple disease areas. We are looking for a Principal Bioinformatics Scientist in the NGS Algorithms and Applications team to support the algorithm development efforts.
In this role, you will collaborate closely with assay scientists, software engineers and other bioinformatics scientist and apply your strong knowledge in next generation sequencing technologies. This will include illumine SBS (sequencing by synthesis), nanopore, etc. to design and develop algorithms for read processing, alignment, and variant (SNV, SV, insertions/deletions, CNV, TMB, MSI) callers etc. This will be used in our products that will affect patient care.
Responsibilities:
* Lead algorithm development effort for NGS applications including conceptualization, method development and implementation of production level algorithms in an Agile environment.
* Follow software development process and deliver and maintain documentation that explains why and how as well as the final design for scientific, marketing, and regulatory uses
* Present internally or externally (peer-reviewed publications or conference proceedings) and communicate updates across multiple functions in the organization. Transfer algorithm to production teams and provide scientific support for updates and maintenance
* Support bioinformatics pipeline to continue development for existing products
Qualifications:
* PhD in Bioinformatics, Computational Biology, Computer Science, Statistics, Mathematics or other quantitative field combined with 4+ years' experience of designing novel algorithms for NGS data analysis for example read processing, variant calling (SNV, insertions/deletions, CNV, SV, TMB, MSI etc.), variant annotation and analyzing large scale complex genomic datasets.
* Experiences in developing novel algorithms, complexity analysis, as well as demonstrated skillset in statistical and mathematical modeling is a Must.
* Experience implementing high-quality and efficient product level code.
* In depth knowledge of sequencing (long and/or short read), cancer molecular biology, bioinformatics tools, statistical methods.
* Proficient with programming languages (C++ and/or Python) in a distributed Linux environment
* Experience with Machine learning / Deep learning (used in NGS context) is a plus.
* Hands-on experience using a workflow management system such as Nextflow or Snakemake, using Docker and cloud computation resource and storage
* Strong written and verbal communication skills with ability to adjust to technical and non-technical audiences
* Result-oriented individual that thrives in collaborative multi-disciplinary teams. Excels at incorporating feedback in a professional manner.
* One or more first/co-first author publication(s) in a high-impact peer reviewed journals is highly desired.
Relocation assistance is not available for this role.
The expected salary range for this position based on the primary location of Pleasanton CA is $111,000-$206,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Who we are
At Roche, more than 100,000 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.
Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.
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.
If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.$111k-206.1k yearly14d ago
Principal Scientist, Multi-OMIC Cytometry
The expected salary range for this position based on the primary location of South San Francisco, CA is $141,500-$262,900.$141.5k-262.9k yearly19d ago
Principal AI Scientist - Multimodal Translational Medicine
The expected salary range for this position based on the primary location of South San Francisco, CA is $165,600- $307,500.$165.6k-307.5k yearly20d ago
Principal Scientist
The expected salary range for this position based on the primary location of Santa Clara, CA is $118,900 - $220,700.$118.9k-220.7k yearly28d ago
Principal Materials/Surface Scientist
The expected salary range for this position based on the primary location of Santa Clara, CA is $130,000 and $160,00.$130k-160k yearly15d ago
Scientist - Complaint Investigation & Resolution
The Scientist (CIR) is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, case documentation, trending analysis and preparing reports, ensuring regulatory compliance and optimal levels of customer satisfaction.$73.2k-135.9k yearly14d ago
Scientist 2 / Scientist 3, Translational Oncology
The Department of Translational Oncology in Genentech Research has an opportunity for a highly motivated Scientist 2/Scientist 3 to join in our mission of developing meaningful therapies for the treatment of cancer. * 3+ years hands-on relevant experience with murine models; at least 8 years of experience is required for the Scientist 3 level The expected salary range for the Scientist 2 position based on the primary location of California is $78,400 to $145,600.00 USD Annual. The expected salary range for the Scientist 3 position based on the primary location of California is $98,200 to $182,400.00 USD Annual.$98.2k-182.4k yearly14d ago
Scientist 3, Immunology Discovery
Department of Immunology Discovery at Genentech is seeking a highly talented, driven and motivated Scientist 3 for the Kim lab to investigate novel pathways, biologics and potential therapeutic targets to treat autoimmune diseases.$98.2k-182.4k yearly21d ago
Clinical Laboratory Scientist Supervisor
Must possess a valid California State Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) license$75k-120k yearly7d ago
