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The Validation Engineer will work collaboratively across functions (e.g. quality, IT, and vendors), assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and lead and execute validation activities method validation, equipment qualification, computer system validation, and method transfer. This role will accomplish objectives by executing activitie
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1. Cross Functional Team Membership Participates in the relevant Clinical Science Team (CST) Participates as a standing or ad hoc member in sub teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross functional integration, coordination and alignment to enable effective and efficient CD plan execution As requested, s
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Operate small scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations. Operate systems that clean and sterilize tanks and filtration systems, including bioreactors, centrifuges, other harvest systems and protein
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We are seeking applicants for this position who possess the following skills and experience Able to operate in a clean room environment by adhering to aseptic processing qualifications and requirements. Able to perform equipment set up and change over. Demonstrate ability to train others on equipment and documentation systems. Adhere to proper documentation (manufacturing tickets and standard oper
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The Validation Engineer will work collaboratively across functions (e.g. quality, IT, and vendors), assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and lead and execute validation activities method validation, equipment qualification, computer system validation, and method transfer. This role will accomplish objectives by executing activitie
Posted Today
Operate systems that clean and sterilize tanks and filtration systems. Prepare solutions for the production process. Review documentation and check all calculations (e.g. tickets, labels, equipment reading). Troubleshoot equipment and process problems. Comply with safety requirements, cGMP, SOP and manufacturing documentation. Use automation to perform production operations. Operate automated syst
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Accountable for managing operational start up activities (process readiness, documents, mock runs, equipment set up). Develop and/or improve departmental capabilities in response to corporate needs, industry practices, and regulatory agency expectations. Provide coordination and issue resolution across HIT Manufacturing Operations, other groups and/or projects. Manage the development and implement
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This position is part of Genentech's Pharma Technical Hillsboro Individualized Therapies (HIT) team working on the individualized NeoAntigen Specific Therapy (iNeST) platform based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis. As a member of the HIT Manufacturing team, you will be supporting the start u
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As the iNeST Clinical Distribution Specialist, you will be part of a cross functional team responsible for the manufacture and supply of an individualized Neoantigen Specific Immunotherapy (iNeST) that is manufactured on a per patient basis. The iNeST Clinical Distribution Specialist will be responsible for managing sample logistics for the manufacture of each patient's iNeST, sample logistics to
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Location Oceanside Essential Perform automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement. Produce and review design drawings and specification documents (URS, FS, DS, etc.). Generate, execute, and review design testing, generate and participate in functional specificat
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We have an exciting opportunity for a talented senior level medicinal chemist to join our Small Molecule Drug Discovery Chemistry Department at Genentech in South San Francisco, CA. The successful candidate will be responsible for driving medicinal chemistry research during the lead identification and optimization stage as part of a drug discovery team. Qualifications Applicants should have >7
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At USMA, we focus on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Genentech organization, USMA has a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and
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Adhere to all plant safety policies and procedures and proactively identify unsafe conditions. Perform safety and housekeeping audits as required. Assist in set up, change over, and test run equipment for various sized vials and packages as required. Supporting the Operations Specialist Maintenance, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required. Per
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Regulatory Documentation (PDRD) is part of the PD Regulatory organization. PDRD interprets the needs of worldwide health authorities, defining and executing the content and documentation strategy to support development and maintenance of global licenses. PDRD leads documentation deliverables across all therapeutic areas and phases of product development, from entry in to human to product divestitu
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We are looking for an individual to fill an Associate Scientist or Scientist position performing laboratory based research in the Investigative Toxicology group within the Department of Safety Assessment. This Investigative Toxicology scientist position will primarily provide independent hypothesis driven research aimed at characterization of potential or identified nonclinical and clinical toxici
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