- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals. RayzeBio, a Bristol Myers Squibb company, is looking for a Scientist I - Method Validation at their Indianapolis manufacturing ... support product development at the RayzeBio manufacturing site in Indianapolis. The Scientist I - Method Validation will report directly to the Manager of… more
- ThermoFisher Scientific (Richmond, VA)
- …to deliver groundbreaking innovations. **Discover Impactful Work:** Performs immunoassay method development, validation , and troubleshooting in support of ... pharmacokinetic, toxicokinetic, pharmacodynamic, and immunogenicity (ADA) sample testing involving novel therapeutics (particularly large-molecule biologics) in the pharmaceutical industry. **A day in the Life:** + Independently performs immunochemistry… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with headquarters in Foster City, California. **Key Responsibilities: ** Analytical Method Validation and Transfer **- Commercial** **Analytical Lifecycle ... Management:** + The Scientist , Analytical Lifecycle Management is vital for the success of Commercial Biologics QC, providing support for strategic leadership and… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …and Abilities:** * Strong understanding of GLP-compliant bioanalytical workflows and method development. * In-depth knowledge of global regulatory expectations (FDA, ... ICH, EMA) for PK and immunogenicity testing. * Skilled in data interpretation and familiar with analytical/statistical software. * Solid foundation in bioanalytical principles including concentration units, calibration curves, and quality controls. *… more
- Kelly Services (Gaithersburg, MD)
- **Assay Transfer, Quality & Validation Scientist (Temporary / Temp-to-Hire)** **Location:** Gaithersburg, MD (On-site) **Duration:** 3 months (possible ... roles will support biological and molecular assay development, optimization/robustness, method transfers, qualification/ validation , and training of staff. You… more
- Kelly Services (Bristol, TN)
- …+ Serve as the **technical SME** for QC laboratories, supporting analytical method development, troubleshooting, and equipment validation . + Analyze laboratory ... **Senior Validation Specialist - Direct Hire (Permanent)** **Location:** Bristol,...+ Play a lead role in the implementation and validation of a new **LabVantage LIMS** , scheduled for… more
- Charles River Laboratories (Mattawan, MI)
- …one operational area + Assist in leading the lab staff in the completion of method validation studies with oversight + Performs all other related duties as ... peers, supervisor, and team + Develop ability to recognize method and/or data issues and communicate them to management...study impact with minimal oversite + Prepare summary of method development data with minimal oversight + Write both… more
- Endo International (Rochester, MI)
- …testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial ... areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. **Job… more
- Fujifilm (Holly Springs, NC)
- …in support of tech transfer and routine manufacturing. * Executes and reviews method qualification and validation activities and maintains lab equipment. * ... **Position Overview** The Scientist 2, QC Chemistry is a technical subject...the LIMS team and IT department to build new method functionality that meets end-user and customer requirements. *… more
- Catalent Pharma Solutions (Baltimore, MD)
- …alignment. + Provide technical leadership and guidance on experimental design and method validation in accordance with ICH and FDA regulatory requirements. ... **Principal Scientist , Analytical Development** **Summary:** Catalent Cell and Gene...and is expected to have extensive experience in analytical method development and validation . Responsibilities include authoring… more
- Catalent Pharma Solutions (Winchester, KY)
- … Scientist work/assist on method development, method transfer, method verification and method validation under appropriate guidance along with ... **Associate Scientist ** **Position Summary** Catalent, Inc. is a leading...client's documents as required including but not limited to specification/ validation reports/test methods/compliance reports etc. to perform gap analysis… more
- Kelly Services (South San Francisco, CA)
- …LC-MS). + Comprehensive knowledge of ICH, FDA, and related regulatory requirements for method validation , method transfer, GMP manufacturing, and analytical ... role will drive late-stage clinical and commercial manufacturing activities, analytical method development, and validation for intranasal drug products. The… more
- Astellas Pharma (Westborough, MA)
- …equipment, including those with computerized systems + Experience in method validation /qualification/verification/transfer **Working Conditions:** + This role ... **QC Scientist I Raw Materials** Do you want to...procedures + Design and perform testing in support of method transfer/ validation /qualification/verification + Review/authorize data and perform… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and CMC functions in establishing product specifications, stability programs, material qualification, method validation , method transfer, and process ... **Overview** The Scientist I, Analytical Development position is responsible for...for some industrial experience. + An appropriate understanding of method development, method validation , and… more
- Endo International (Rochester, MI)
- …+ Evaluates, troubleshoots/improves existing analytical methods when necessary + Prepares method validation protocols, reports, and analytical test methods + ... analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing… more
- Merck (Rahway, NJ)
- …output(s) meet design input(s). + Lead establishment of test methodologies, including method development and validation , internally or externally, per design ... and leading activities (eg, strategy/ plan, protocol(s), report(s), test method development/ validation , etc.) requiring cross-disciplinary project teams. +… more
- Amgen (Thousand Oaks, CA)
- …lifecycle management activities including method remediation, improvements, and support method and validation and transfers + Contribute to global regulatory ... of patients while transforming your career. **Process Development Senior Scientist ** **What you will do** Let's do this. Let's...chapters, as well ICH guidance documents related to analytical method transfer and validation + Experience with… more
- Fujifilm (College Station, TX)
- …or assay Tech Transfer of recombinant biopharmaceutical protein analytical methods. Late-stage method validation experience is also highly desired. + Managing a ... entering into QC. The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and… more
- Herbalife (Torrance, CA)
- …ROLE:** The Analytical Scientist II is a technical expert in analytical method development and validation . This role focuses on creating robust, efficient, ... Analytical Scientist II Category: Quality Position Type: Regular Full-Time...+ Provide hands-on training and mentorship to chemists on method execution, validation principles, and data interpretation.… more
- Amgen (Thousand Oaks, CA)
- …current Good Manufacturing Practices (cGMP) quality standards. Additionally, the Scientist will support a chemo-metric spectroscopy-based analytical method ... transform the lives of patients while transforming your career. **Process Development Scientist (Attribute Sciences)** **What you will do** Let's do this! Let's… more
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