- 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...clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in… more
- Eisai, Inc (Nutley, NJ)
- …SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills ... of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management,… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... with device design, requirement management, FMEA, design verification, design validation , statistical sampling, and control strategyExperience with regulatory fillingsWorking… 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. (Rahway, NJ)
- …- This role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal environmental conditions for product quality, and support ... candidate will have strong technical expertise in HVAC design, maintenance, and validation within a highly regulated environment, combined with leadership skills to… more
- Merck & Co. (Rahway, NJ)
- …tech transfer to internal and external manufacturing sites, process validation , second generation process development and health authority licensure.-You'll lead ... filings (IND, MAA, BLA) and supporting inspections with multiple agencies ( FDA , EMA, JNDA, TGA).-Leadership:-Establish, manage and support CMC teams, and align… more
- Insmed Incorporated (San Diego, CA)
- …and validation according to regulatory guidelines such as ICH, FDA , and cGMP, evaluating method characteristics like specificity, sensitivity, accuracy, and ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene Therapy ... to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate… more
- BioAgilytix (Durham, NC)
- …visibility into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA , EMA, or ... Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and… more
- Merck & Co. (Rahway, NJ)
- …facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong understanding ... process and deliverables (eg, equipment fabrication, FAT, SAT, qualification / validation )Current Employees apply HERE Current Contingent Workers apply HERE US and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems. Responsibilities ... processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to determine… more
- Merck & Co. (Rahway, NJ)
- …/ engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive new ideas, but also have pragmatic ... options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong experience… more
- Aequor (Hicksville, OH)
- …paperwork for upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels for individual ... and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is...and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. This individual will ... other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... quality systems, or learning management systems.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well… more
- Aequor (Cincinnati, OH)
- …Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data ... COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer… more
