- 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
- 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
- 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
- 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
- Aequor (Davie, FL)
- …also support various day to day trouble shooting for operational equipment , facilities and innovation activities Key Responsibilities: Automation Systems Design & ... Use Copilot and Power Fx to simplify app creation and automate repetitive tasks. Validation & Compliance o Ensure systems meet GxP, FDA, and ISO standards through… more
- Collectors Holdings, Inc. (Santa Ana, CA)
- …associated reports Perform other duties as assigned Support of maintenance and equipment repair actions, including validation of repairs and verification of ... The Process Engineer will assist with process development, specification, validation and implementation, efficiency improvements, 5S implementation, implementation of… 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)
- …and link between analytical methodologies for analysis. - Experience with qualification, validation , and transfer of assays to a GLP or regulated laboratory ... presentations - Strong external network to benchmark competitors and equipment vendors - Experience in high-throughput experimentation and data-rich experimentation… more
- BioAgilytix (Durham, NC)
- …Part 11).Business continuity and resilience (eg, backup/restore validation , disaster recovery planning).Minimum Preferred Qualifications - ... is an on-site role in Durham, NC Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsThe benefits of joining… more
