- Legend Biotech USA, Inc. (Raritan, NJ)
- …in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for ... Cell/Gene Therapy experienceMinimum of 5 years of experience of progressive leadership roles in a cGMP operation, with prior Biologics and/or cell therapy operations experience preferred.Prior experience leading large multilevel teams.A history of developing… more
- Genscript USA Inc. (Piscataway, NJ)
- …improve utilization of automation equipment . Provide support in equipment operation, installation, debugging, validation , acceptance, ongoing maintenance, ... solution design, and vendor communication for the introduction of automation equipment into molecular biology production lines. Proficiently operate and develop… more
- Aequor (Hicksville, OH)
- …directed by engineering personnel. Plan and execute level upgrades in support of equipment improvements and CAPAs. Execute validation dry runs to identify ... repairs and maintains a wide variety of Compounding, Packaging and Facilities equipment , including but not limited to mixing kettles, washers, mills, pumps, tube… more
- Saint Francis Hospital - Bartlett (Bartlett, TN)
- …to other laboratory personnel. Additional responsibility includes assisting with new equipment validation and implementation, employee training and competency ... to other laboratory personnel. Additional responsibility includes assisting with new equipment validation and implementation, employee training and competency… more
- Merck & Co. (Rahway, NJ)
- …and device product development, such as manufacturing process development and validation , design control, risk management, material and molding, design validation ... input(s).Lead establishment of test methodologies, including method development and validation , internally or externally, per design verification strategy.Lead strategy… more
- Merck & Co. (Rahway, NJ)
- …support from early stage through launch and supply, including components, process, and equipment , as well as qualification and validation , medical device design ... for standard finished goods images and packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to… more
- Merck & Co. (Rahway, NJ)
- …support from early stage through launch and supply, including components, process, and equipment , as well as qualification and validation , medical device design ... for standard finished goods images and packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to… more
- CHRISTUS Health (New Braunfels, TX)
- …to meet the needs of New Braunfels' strong population growth. Innovative equipment and procedures are utilized, including an Outpatient Imaging Center, orthopedic ... through successful completion of the designated organizational entry competency validation and a Perinatal Services-specific competency validation .Completion of… more
- Aequor (Davie, FL)
- …Review and analysis of the analytical and statistical data to support the pre- validation work. Analysis of data to ascertain the data meets protocol and product ... criteria: writes deviation reports and technical assessments as required. Supports pre- validation commercial scale report that includes detailed summary of the … more
- Metrowest Medical Center (Framingham, MA)
- …to other laboratory personnel. Additional responsibility includes assisting with new equipment validation and implementation, employee training and competency ... to other laboratory personnel. Additional responsibility includes assisting with new equipment validation and implementation, employee training and competency… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cross-functional teams to design and implement cell therapy processes, manage equipment qualification strategy, and support process validation activities for ... and IQ/OQ/PQ testing.Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating,… more
- AUROBINDO (Durham, NC)
- …for study types ranging from reverse engineering to method development/ validation to product characterization.. Drafts protocols and performs experiments ... owner, software system owner, metrology, hazardous waste management, software validation , ELN template development/ validation , instrument qualification, etc.Writes… more
- BioAgilytix (Durham, NC)
- …In this role, you will take ownership of assay development, validation , and sample analysis using advanced chromatographic and mass spectrometric techniques. ... shape the future of healthcare.Essential Responsibilities:Independently lead assay development, validation , and sample analysis of biologics, proteins, peptides, ADCs,… more
- Merck & Co. (Rahway, NJ)
- …from early stage through launch and supply, including components, process, and equipment , as well as qualification and validation .Demonstrated experience in a ... leadership role; managing technical teams supporting packaging and/or combination product assembly and packaging.Strong problem-solving and decision-making skills with an ability to determine interrogate the science, identify true requirements, and detect… more
- Abrazo Arrowhead Campus (Glendale, AZ)
- …personnel. Additional responsibilities may include billing and inventory management, equipment selection, validation and implementation; document control (SOPs); ... duties, maintenance and advanced troubleshooting of laboratory instrumentation and equipment ; acts as resource to other laboratory personnel. Has additional… more
- BioAgilytix (Durham, NC)
- …best suited for someone with deep expertise in method development, GxP-compliant validation , and both 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)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... with clients to assure successful on time execution of assays, validation , and sample analysis under GxPs.Prioritizing tasks and managing schedules efficiently.Meet… more
- AUROBINDO (Durham, NC)
- …throughputSupport deplloyment of the electronic laboratory notebook system through training, validation script review, and validation protocols and reports. ... technical review of documentation is required.Previous experience with reviewing software validation scripts and documents is preferred.Must be able to monitor for… more
- AUROBINDO (Dayton, OH)
- …(HPLC/UPLC, Dissolution, GC, UV-Vis, and other routine instruments).Perform analytical method validation for various tests including but not limited to assay, ... and perform tests accurately.Prepare and/or review Test Procedures, SOPs, Validation Protocols/Reports as assigned.Perform maintenance and calibrations of laboratory… more
- Merck & Co. (Rahway, NJ)
- …selected candidate will be responsible for method optimization, phase-appropriate validation , early and late-stage analytical transfers, analytical life cycle ... and facilitate ongoing enhancement of laboratory processes. Manage laboratory equipment , laboratory supplies and critical reagent inventories. Additional responsibilities… more
