• Daiichi Sankyo, Inc. (Bernards, NJ)
    …procedures. Provide expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
    HireLifeScience (09/24/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (South San Francisco, CA)
    …in drug discovery strategies and processes throughout target identification and validation , lead optimization, preclinical candidate selection, and early ... as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area… more
    HireLifeScience (11/06/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (South San Francisco, CA)
    …physiological energetics in the broader context of cardiometabolic disease.-Key Responsibilities: Lead projects through target identification and validation , hit ... through various stages of drug discovery, including - target identification and validation , building a project team, developing research operating plans (ROPs), and… more
    HireLifeScience (11/02/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Rahway, NJ)
    Job Description Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical ... within the Development Sciences and Clinical Supplies (DSCS) organization and lead a group of exceptionally talented scientists supporting externalized analytical… more
    HireLifeScience (10/29/24)
    - Save Job - Related Jobs - Block Source
  • BioAgilytix (San Diego, CA)
    …LIMS systemServe as lead scientist on assay dev projectServe as lead scientist on validation or qualificationPresent data to clientsIndependently write plans ... and reports for validation or qualificationResponsible for prompt identification and notification of...according to GLP guidance or SOPsFollow GLP guidance/SOPs for validation or for qualification of assaysRun assays independently; (biomarker,… more
    HireLifeScience (10/16/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Rahway, NJ)
    …technology and experience with test method development, testing, and method validation for various product images (vials, syringes, cartridges, and injectors) and ... vaccine products.The successful candidate will have experience in method development, validation and/or testing of typical injectable product presentations and be… more
    HireLifeScience (11/15/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (South San Francisco, CA)
    …in translational cell models, mechanistic pharmacology, and biomarker and lead discovery to join our Quantitative Biosciences (Pharmacology) department. The ... experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate will work closely with a team of… more
    HireLifeScience (11/06/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Rahway, NJ)
    …and fantastic user experience.You will be responsible for identifying opportunities that lead to the growth of our products through constant improvement and ... members.Ensure ongoing compliance with regulatory safety, Good Practice (GxP) and Validation requirements when required. Ensure all systems are designed, built, and… more
    HireLifeScience (11/08/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Rahway, NJ)
    …to internal and external manufacturing sites, manufacturing investigation, process validation , and authoring of regulatory submissions. -Under the general scientific ... late-stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.-Drives division wide… more
    HireLifeScience (11/09/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Durham, NC)
    …candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for microbiological testing and environmental monitoring.- ... to identify, to ensure successful execution of method transfer or method validation activities.Apply project management concepts and techniques as they relate to… more
    HireLifeScience (11/05/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (West Lebanon, IN)
    …of best practices Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems Lead the ... knowledge for the development/refinement and implementation of the GEP program and validation standards based on risk-based practices as prescribed in ASTM E2500.… more
    HireLifeScience (10/29/24)
    - Save Job - Related Jobs - Block Source
  • BioAgilytix (Durham, NC)
    …life-saving therapeutics to the patients who need them.Essential ResponsibilitiesServe as lead scientist on assay development, validation , and sample analysis ... project Follow GMP guidelines for validation of assays and sample analysisIndependently write plans and reports for validation and sample analysisResponsible for… more
    HireLifeScience (10/31/24)
    - Save Job - Related Jobs - Block Source
  • BioAgilytix (Durham, NC)
    …compliance with laboratory standards. Instrumentation Integrationo Serve as the technical lead for integrating both simple and complex lab instruments with ... flow and availability within LabVantage. System Configuration and Customizationo Lead configuration tasks within LabVantage to align with BioAgilytix's laboratory… more
    HireLifeScience (11/12/24)
    - Save Job - Related Jobs - Block Source
  • Aequor (Bothell, WA)
    …and quality control organizations. This position requires a passion for IT, validation , and compliance. Project management and business analyst skillsets within the ... environment.Excellent verbal and written communication skills.The ability to plan and lead small and medium size projects and enhancements.The candidate needs to… more
    HireLifeScience (10/24/24)
    - Save Job - Related Jobs - Block Source
  • Legend Biotech USA, Inc. (Raritan, NJ)
    …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT....solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity,… more
    HireLifeScience (10/24/24)
    - Save Job - Related Jobs - Block Source
  • Genmab (Plainsboro, NJ)
    …expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible ... contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
    HireLifeScience (10/18/24)
    - Save Job - Related Jobs - Block Source
  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all ... any problems related to data transfers, data structure deviations or validation issues. Complies with the protocol, Policies, SOPs, external/internal standards,… more
    HireLifeScience (10/10/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Rahway, NJ)
    …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... and productive processes, through scale-up, tech transfer, process characterization, validation and filing.- This role involves hands-on process development at… more
    HireLifeScience (10/02/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (West Lebanon, IN)
    …at our commercial pharmaceutical bioproduction plant. Relationships Reports to: Lead Engineer Number of subordinates with direct/indirect referral: None Essential ... related issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation… more
    HireLifeScience (11/13/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Boston, MA)
    …diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets, including the design of preclinical and clinical ... for the design and execution of early clinical development strategyTaking a lead role in developing and executing clinical pharmacology studies for programs in… more
    HireLifeScience (11/07/24)
    - Save Job - Related Jobs - Block Source