- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as ... systems validation , equipment, utilities, and facility qualification, process validation , shipping validation , and data integrity.Key Responsibilities… more
- BioAgilytix (Durham, NC)
- …UiPath or Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data ... with RPA platforms (eg, UiPath, Microsoft Power Automate) to independently automate data validation checks and routine compliance tasks.Skilled in developing and… more
- Formation Bio (New York, NY)
- …that adheres to CI/CD and data governance best practices. Implement data validation and observability frameworks to ensure quality, trust, and ... and more efficiently.About the PositionWe're looking for a Senior Data Engineer to join the Data Platform team at Formation Bio to help transform Electronic… more
- Tris Pharma (Monmouth Junction, NJ)
- …activities, in liaison with PD/QA/QC/Regulatory AffairsDesigns experimental plans; Critically analyzes data and information gathered during method validation for ... Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and… more
- Novo Nordisk Inc. (Durham, NC)
- …efforts. Identify and share better practices, to include increasing awareness of data management standards & validation to create improvements in methods, ... & simplicity in our processes. Responsible for executing advanced data analysis projects that support site data ...advanced data analysis projects that support site data and digitalization efforts with respective complexity (according to… more
- Merck & Co. (Rahway, NJ)
- …Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data Analysis, Diversity and Inclusion ... Job DescriptionTitle: Specialist, Metrology and Validation , Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionAs AD/Director of Data Science - Platform at Formation Bio, you will lead one of two ... critical arms of our Data Science function, focusing on building predictive capabilities that...Foster a culture of rapid execution while maintaining rigorous validation standards About YouRequired Qualifications PhD in computational sciences… more
- Aequor (Devers, TX)
- …Update, create, and approve all necessary UAT test scripts. DCT Verification and Validation : Approve Site Procurement Data Load Files in support of simulated ... ensuring the successful migration from Oracle to SAP, focusing on procurement data and processes. The ideal candidate will have extensive functional and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Precision Genetics group within Data , AI and Genome Sciences (DAGS). Our department is recruiting a Senior Director, who will serve as the ... Computational Biology lead for Cardiometabolic Drug Discovery Data Science. We are seeking an experienced computational biologist with a proven track-record in… 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,...21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system… more
- Genmab (NJ)
- …discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information ... analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners in collaboration with the programmer… more
- Twist BioScience (South San Francisco, CA)
- …operations. This critical role will drive efficiency, quality, and robust data integrity within a highly automated environment. The effective utilization and ... requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing… 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
- 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 ... Involves hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to… 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 ... budget, and revenue management.Act as primary client contact, presenting data , ensuring clear communication, and aligning project deliverables with client… 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. (Rahway, NJ)
- …Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, analyze data , ... biological molecules.Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.Proficiency… 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 ... and process improvements. Document and evaluate experimental results and perform data verification and trending. Provide technical expertise and guidance to support… more
- Aequor (Pearl River, LA)
- …with a passion for using high-dimensional single cell immune profiling data in conjunction with innovative computational approaches and systems immunology knowledge ... BCR sequencing, and host immune profiling. This role will integrate multi-omics data with preclinical/clinical data and provide scientific insights to immune… more
- Eisai, Inc (Nutley, NJ)
- … Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively manage and guide ... Clinical Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but… more
