- Tris Pharma (Monmouth Junction, NJ)
- …degree in Chemistry or related science field and minimum 8 years' experience in analytical/ method development or method validation in the pharmaceutical or ... need for an experienced TEMPORARY Analytical Research and Development Scientist III. This is a temp to possible permanent...related science field and minimum 5 years' experience in analytical/ method development or method validation … more
- Merck & Co. (Rahway, NJ)
- …analysis and testing, medical device design controls, risk management, test method /fixture development, design verification and validation , injection molding, ... Job DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent) Our company's Device Product & Process… more
- Eisai, Inc (Exton, PA)
- …release and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on testing in ... release and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on testing in… more
- Insmed Incorporated (NJ)
- …the Role:We're seeking a highly motivated, creative, and passionate Senior Scientist to join our multidisciplinary team advancing therapeutics for inflammatory and ... diseases. In this role, you will lead the development, optimization, and validation of in vitro functional and translational assays, drive microscopy experiments… more
- Merck & Co. (Rahway, NJ)
- …Background in analytical development or commercialization, with knowledge of method development, validation , specification setting and justification. Practical ... the guidance of dCMC Regulatory-Authoring Leadership, the Associate Principal Scientist , Regulatory Authoring Business Owner, will-optimize regulatory authoring processes… more
- 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
- 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
- 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
- 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
- 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
- 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
- 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
