- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... with company policies, SOPs, and state, federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Validation Specialist role is an exempt level position with...position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Specialist, Metrology and Validation , Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External ... Capabilities, Validation , and Compliance (ECVC) department of our company's Research...Laboratories Division is seeking applicants for a Metrology and Validation Specialist position available at the Rahway, New Jersey… more
- Merck & Co. (Rahway, NJ)
- …medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to positively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This ... position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best… more
- Merck & Co. (Rahway, NJ)
- …GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and ... approve qualification protocols and summary reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- Tris Pharma (Monmouth Junction, NJ)
- …field and minimum 4 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology field ORMasters degree in Chemistry ... field and minimum 2 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology field ORPhD in Chemistry or related… more
- Twist BioScience (South San Francisco, CA)
- …requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing ... capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES solutions comply with GxP regulations… more
- BioAgilytix (Durham, NC)
- …for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass ... project deliverables with client timelines and expectations.Lead assay development, validation , and sample analysis of biologics, proteins, peptides, ADCs, and/or… more
- BioAgilytix (San Diego, CA)
- …infrastructure.Essential ResponsibilitiesParticipates in implementation planning, qualification and/or validation of laboratory systems and softwareAuthors and ... etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data integrity), following 21… more
- Merck & Co. (Rahway, NJ)
- …Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, analyze data, and ... biological molecules.Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.Proficiency… more
- BioAgilytix (Durham, NC)
- …Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and ... into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA, EMA, or sponsor… more
- Lundbeck (Bothell, WA)
- …a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to… more
- Merck & Co. (South San Francisco, CA)
- …a clinical perspective into the earliest stages of target identification and validation , and executing clinical studies to evaluate the relevance of potential ... interrogate biological activity in humans.Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or… more
- Insmed Incorporated (San Diego, CA)
- …and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage ... candidates and troubleshooting technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP,… more
- Aequor (East Syracuse, NY)
- …for supporting analytical method lifecycle activities including method development, qualification, validation , and technical transfer of methods for the testing of ... regulatory submissions related to analytical procedures, method development and validation , specifications, reference standards, extended characterization, and product stability/… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Genmab (NJ)
- …according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and ... listings etc.Review assay validation reports, as applicablePerform exploratory analysis, ad hoc analyses, and modelling of dataReview and approve randomization and… more
- Merck & Co. (South San Francisco, CA)
- …a clinical insight into the earliest stages of target identification and validation , and executing clinical studies to evaluate the relevance of potential targets ... interrogate biological activity in humans.Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or… more
- Repligen (Rancho Dominguez, CA)
- …manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes projects or ... and training of best practices. Apply statistical tools to support validation and process optimization efforts. Drive innovation in filtration systems and… more
