287 jobs found in pleasanton

RMD BioSpecimen Management Scientist I Position, Location and Scope RMD is seeking a qualified and highly motivated individual for the role of Scientist I in BioSpecimen Management to support Culture Collection and Panel production activities. The BioSpecimen Management function at Roche Molecular Diagnostics (RMD) is a centralized service function which supports the acquisition, characterization, and management of biological materials, as well as build of select panels for clinical research and cultivation and characterization of various Microorganisms and Mammalian cell lines. The Scientist I position will facilitate the daily operations associated with fulfilling service requests for Culture collection and panel activities, while providing best-in-class simple biological solutions to our customers to drive innovation at Roche Molecular Diagnostics (RMD). This position will be based at RMD in Pleasanton, California. Specific Responsibilities Under supervision,...

ESSENTIAL FUNCTIONS: Develops, validates, and applies methods for various genomics methods mainly focused on sequencing. Develops project timelines and utilizes time management practices and tools to manage demands and deadlines and to deliver on key project milestones. Determines all chemicals, reagents and supplies needed for a project; develops a strong knowledge of all related third-party vendors and their technologies and products. Processes nucleic acid isolation and quantification, PCR amplification, library preparation, plate normalizations. Accurately and consistently records experimental methods, materials and results in electronic laboratory notebooks. Analyzes data, evaluates results, forms conclusions, and determines future experiments. Uses broad knowledge of molecular biology technique to proactively troubleshoot assays, resolve technical issues and challenges, and perform data interpretation. Collaborates with other R&D functions to transfer new assays...

BioSpecimen Acquisition Senior Scientist Position, Location and Scope BioSpecimen Management (BSM) function at Roche Molecular Diagnostics (RMD) drives the collection, characterization, construct, and management of biological materials and tailored solutions to empower innovation furthering business strategies at Roche Molecular Solutions (RMS). This position, reporting into BSM, facilitates the planning and implementation of sample collection projects in collaboration with strategic partnerships to deliver diverse biological solutions fit to effectively address RMS Life Cycle Team objectives. This position is based at RMD in Pleasanton, California. Specific Responsibilities Develops biological material collection processes in collaboration with the team, and facilitates the implementation at BSM service locations. Delivers on biological material collection projects, per commitments and prioritizes resources to ensure flexible delivery to Roche clients. Develops and...

ROLE SUMMARY: The System Engineer II for Roche Sequencing Solutions will be part of the system development team focusing on the development of a cutting edge next-generation sequencing (NGS) system for IVD assays and applications. The individual will be part of a team tasked with the design and development of a sample preparation automation solution for the NGS platform. ESSENTIAL FUNCTIONS: Works under general supervision, to conduct and monitor laboratory experiments utilizing established and published procedures, and technical and theoretical understanding. Hands-on with a strong instrument/platform development background, the candidate will be asked to troubleshoot systems, identify opportunities for quality improvements, provide root causes of complex HW-SW interaction problems, and communicate test results and corrective recommendations to the team. Summarizes experimental results, and reviews conclusions with supervisor/project leader Communicates results of...

Essential Functions: Designs, plans, and executes studies in support of multiplexed PCR IVD test development utilizing established and innovative procedures. Applies scientific knowledge and accumulated experience to complete projects. Contributes to assessing new technologies that have potential to meet current and future diagnostics needs. Contributes to the definition and timely achievement of overall project goals. Makes recommendations, and when appropriate, acts independently to resolve scientific problems encountered during experimental procedures to improve productivity of results. Ensures activities are consistent with project critical path, and responds appropriately to changing priorities. Accurately and consistently records experimental methods, materials and results in electronic laboratory notebooks. Analyzes data, evaluates results, forms conclusions and implements/documents process improvements. Integrates previous and current results to determine next...

The RSS Development Process & Support team is in need of a Development Process Scientist II who will participate in the development and adoption of laboratory, quality system, and design control processes. The scientist will author, review, manage, and implement processes for IVD product development laboratories, reagent, and assay development activities. In addition, the individual will provide subject matter expertise to internal R&D teams on best practices, methods, and tools. The scientist will support activities to harmonize and improve quality management system, laboratory, and design control processes. Experience in next generation sequencing, assay, or reagent product development with demonstrated knowledge in quality management systems, Good Laboratory Practices, Good Documentation Practices, ISO 13485:2016, IVD-R, and Quality System Regulations is highly desired. The successful candidate is technically proficient, creative, collaborates well with others, can...

The Senior Manager, Medical Affairs, Blood Screening will participate in the execution of key initiatives to support the global utilization of Roche Molecular infectious diseases donor screening products. Activities may include, but are not limited to, developing scientific publications, providing medical support for the design and analysis of product evaluations, managing investigator-initiated studies, designing and managing Roche sponsored studies, planning scientific symposia, and providing scientific presentations to internal and external audiences. The Senior Manager, Medical Affairs, Blood Screening will be expected to interact with members of the RMS blood screening global business team, affiliates, and key opinion leaders. Job Description: Work with the relevant disease area Life Cycle and Business teams including Life Cycle Leaders, International Business Leaders, and International Product Managers to support commercialization of Blood Screening products. Provide...

A Systems Support Engineer provides service on Roche instruments and systems used for Research, Development, and Clinical Operations activities located both internally and at external sites. The Systems Support Engineer is responsible for installation/de-installation, qualification, preventative maintenance and repair of complex medical device instruments and software. The Systems Support Engineer troubleshoots instrument hardware-software problems by using service software, reviewing system-generated problem reports/error codes, and performing root cause analyses. Being a team player is essential since this position interfaces daily with coworkers as well as various interdisciplinary functional areas within the organization. The Systems Support Engineer must be committed to customer satisfaction, with the ability to demonstrate outstanding interpersonal skills and solid judgment. This position is based in-house, but some domestic and international travel is to be expected....

Essential Job Functions & Major Contributions for a Senior Systems Support Engineer: Perform the following activities according to approved procedures: Preventative maintenance (PM's) Installation/operational qualifications (IOQ's) Troubleshooting, part replacement and repairs Install/deinstall/relocate instruments and computer work stations Install or upgrade system and application software Establish network connections for remote access to externally placed instruments All activities performed are documented accurately and in a timely manner in the electronic instrument database according to approved procedures Provide limited IT support for in-house lab based instruments and the secure data repository Address field service calls (both in-house and externally) according to dispatch procedures and triage the issue(s) with guidance from senior team members and coworkers as appropriate Build effective customer relationships in a professional manner through...

Roche Sequencing Solutions (RSS) is building on Roche's legacy of innovation to transform next-generation sequencing and its application. The RSS Instrument and Lab Services (ILS) team is an internal service organization that creates, manages, and improves processes, labs, and infrastructure to support product development teams. ILS is in need of a Laboratory Supervisor who oversees laboratory management practices and coordination in research and product development laboratories. The role involves conducting projects for process improvement, lab user education, and quality/safety compliance. As an internal service orientation supporting over 150 lab users, ILS is looking for a candidate with excellent written communication and public speaking skills, and a professional customer-service oriented mindset. The Laboratory Supervisor is responsible for the supervision and coordination of operations in Roche Sequencing Solutions - Pleasanton laboratory areas. The individual will...

Responsibilities: Practices and mentors in the use of company concepts, policies and procedures, familiar with and follows standard practices. Applies functional expertise routinely on the job. Receives general direction and exercises considerable 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 and solves technical challenges. Identifies and implements improvements to work processes. Creates potentially patentable components for systems, or processes. Designs, plans and executes project related tasks. Designs and executes experiments to test hypothesis related to project outcomes. Applies advanced scientific knowledge to projects; determines priorities for experiments. Independently designs and executes experiments. Utilizes DOE as appropriate. Assures experimental quality through sound, independent,...

The Manager Regulatory Affairs will support Roche Sequencing Solutions products. This position will represent regulatory on product development core teams and will be responsible for all related regulatory activities including defining regulatory strategies and submissions. Responsibilities: Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products (including compliance). Manages the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings. Monitors and assesses Regulatory developments (e.g. Federal Register publication/notices, FDA guidelines) related to the Company's products. Reviews product labeling to ensure conformance with Regulatory requirements and/or...

You will function as the Safety, Health & Environmental (SHE) Business Partner for your assigned functional area: Environmental and Sustainability. In addition, you will fulfill site-wide responsibilities for specific program area ownership. Expected to work on projects across the business functions, business units, and our business area. Applies extensive knowledge and skills to complete a wide range of difficult tasks. Acts independently to determine methods and procedures on new assignments. Consults with management in the understanding of policies, procedures, programs, and company directives to ensure compliance. Duties are diverse and complex often involving research, analysis and solution development. Possesses and applies a comprehensive knowledge of a particular field across multiple business functions. Plans, conducts and oversees work involving large and important/complex projects. May provide direction and guidance to more junior SHE staff. Reviews...

As a Senior Regulatory Specialist I, you will be responsible for supporting the creation, review and submission of new and existing products. Working closely with cross-functional teams is a key part of this role. Responsibilities: Works under moderate guidance and is responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company. Compiles materials required in submissions, license renewals and annual registrations. Keeps abreast of regulatory procedures and changes. Coordinates the collection of documents, records, reports and data from Development, Clinical Affairs, Quality and Operations Departments for inclusion in regulatory documents. Helps with the preparation of submissions for FDA product approval including 510(k)s, PMAs, INDs, BLAs as assigned. Assists in the review of product labeling/advertising to ensure compliance with federal regulations. Assists in the preparation of international...

Impact Healthcare Roche Sequencing is not only changing science, but we are changing lives! Our team is pushing the boundary of technology with next-generation genomic sequencing. You will develop products that scientists and others in the life sciences will use to diagnose, find treatments, and eventually beat diseases like cancer. Impact Healthcare Roche Sequencing is not only changing science, but we are changing lives! Our team is pushing the boundary of technology with next-generation genomic sequencing. You will develop products that scientists and others in the life sciences will use to diagnose, find treatments, and eventually beat diseases like cancer. Make a Big Difference Do you enjoy experimenting on groundbreaking technology? If so, be prepared to love your job with us! We are looking for a Principal Bioinformatics Scientist to support early Research & Development efforts for the production of assays and reagents which have a global impact on...

Job Responsibilities - 80% Remote based position Responsible for Medical Device Vigilance program, including but not limited to, ensuring potentially reportable incident /potential safety incident criteria is maintained/updated at the divisional level. Responsible for the global adverse event reporting (AER) program, including but not limited to, Medical Device Reporting assessments and submissions, Manufacturer Incident Report assessments, communications to regulatory authorities, represent Quality in Product Care Quality Teams. Accountable for ensuring recall processes adhere to global regulations and internal procedures. Ensures corrections, removals and recalls are managed effectively and efficiently including ensuring regulatory compliance and technical accuracy for all necessary recall documentation (i.e. 21 CFR 806, Urgent Medical Device Correction, Field Safety Corrective Action, etc.) Leads Health Hazard Evaluation (HHE) activities with collaboration from Technical...

Summary The System Engineer II for Roche Sequencing Solutions will be part of the system development team focusing on the development of a cutting edge next-generation sequencing (NGS) system for IVD assays and applications. The individual will be part of a team tasked with the design and development of a sample preparation automation solution for the NGS platform. Responsibilities Works under general supervision, to conduct and monitor laboratory experiments utilizing established and published procedures, and technical and theoretical understanding. Hands-on with a strong instrument/platform development background, the candidate will be asked to troubleshoot systems, identify opportunities for quality improvements, provide root causes of complex HW-SW interaction problems, and communicate test results and corrective recommendations to the team. Makes recommendations to resolve problems encountered during experimental procedures. Assumes responsibility for accuracy,...

As a Manager Regulatory Affairs within Roche Sequencing Solutions, you will be responsible for supporting the regulatory strategy and submissions for new and existing products. Responsibilities: Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products (including compliance). Manages the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings. Monitors and assesses Regulatory developments (e.g. Federal Register publication/notices, FDA guidelines) related to the Company's products. Reviews product labeling to ensure conformance with Regulatory requirements and/or approved product claims. May serve as a contact with affiliates to achieve international...

The Summer @ Roche Intern Program has been developed to provide students with a fun yet rewarding summer through hands-on experience and numerous opportunities to network with other interns as well as employees in the organization. Additionally, we help our students meet their career development and educational goals while potentially building a future with the Roche organization. Leveraging the education you received already, we hope to give you an opportunity to grow and develop with us! Program Requirements: Currently enrolled in an accredited college/university during program calendar year 2021. Completed at least 2 years of college/university to be eligible for the program. Must have a ≥3.0 GPA; please attach a copy of your transcript in order to be considered for this internship opportunity. Minimum availability of 12 weeks (Required start on or before program Welcome Reception and end date on or after Summer End Poster Symposium). Previous experience in the job...

The Summer @ Roche Intern Program has been developed to provide students with a fun yet rewarding summer through hands-on experience and numerous opportunities to network with other interns as well as employees in the organization. Additionally, we help our students meet their career development and educational goals while potentially building a future with the Roche organization. Leveraging the education you received already, we hope to give you an opportunity to grow and develop with us! This is a 12-week student internship position within the COBM's cPM group. The selected intern will apply their education and skills to support daily cPM project planning activities or a cPM functional initiative under the guidance of a Clinical Project Manager or the Head of Clinical Project Management. Projects may involve collaboration with other COBM functional leadership and/or functional departments outside the COBM. This internship is an excellent opportunity to exercise clinical...