- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Small- Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and ... SSO pilot plant enables gain of critical internal experience with scale -up of manufacturing GMP steps, demonstration of new manufacturing technology/processes,… more
- Twist BioScience (South San Francisco, CA)
- …skills to design and implement robust, scalable computational pipelines for large- scale NGS data processing and interpretation.This role is critical in advancing ... reliability and performance.Design and implement data storage solutions for large- scale genomic datasets, balancing accessibility, cost, and efficiency.Develop standardized… more
- Merck & Co. (Rahway, NJ)
- …fermentation and downstream process development and optimization, as well as process scale -up and scale -downDemonstrated capability to develop and execute an ... to address issues of process design, robustness and productivityExperience with process scale -up and technology transfer, moving from laboratory to pilot plant or… more
- Merck & Co. (Rahway, NJ)
- …products in our expanding late-stage biologics portfolio.Drive Innovation: Conduct laboratory- scale and manufacturing- scale studies to support commercial process ... preparative chromatography, and filtration techniques.Experience in pilot or commercial scale manufacturing of biological molecules.Familiarity with late-stage process development,… more
- Eisai, Inc (Exton, PA)
- …leading and building a scientific team focused on the technology transfer, scale -up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug ... regulations. The Associate Director is also responsible to ensure successful scale -up and technology transfer of new production processes and technologies into… more
- Merck & Co. (Rahway, NJ)
- …implement strategy, conduct scientific research from the laboratory to commercial scale , step across boundaries and implement novel innovations during drug product ... including drug-device combination products for biologicsExperience with process design and/or scale -up in the clinical or commercial space, including process flow… more
- AUROBINDO (Dayton, OH)
- …very hands-on. Must have experience in development to large scale submission batch manufacture. ResponsibilitiesSenior Scientist with previous industrial experience ... product developmentExperience working with projects from bench-top stage to large scale manufacture of submission batchesShould have a sound knowledge of… more
- Aequor (North Creek, WA)
- …operations. This role will support late stage and commercial projects through bench scale and pilot scale cell culture experiments. The ideal candidate would ... culture Building, maintaining, and cleaning benchtop bioreactor cultures; supporting pilot- scale (50-200L) single-use bioreactor through equipment setup, culture maintenance,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale . The Process Engineer I will work alongside Process Associates and ... day issues in manufacturing related to: deviations, equipment troubleshooting, small scale process development, SOP review, escalating complex issues to appropriate… more
- AUROBINDO (Durham, NC)
- …date of all material stored in the warehouse.Perform daily verification of floor scale to ensure that the scale is providing accurate information.Check and ... perform daily inspection of electric forklifts and electric hand trucks.Provide assistance in movement of the material to sampling team and dispensing team.Maintain record keeping of all material movement within the warehouse.Inspection and loading of finished… more
- Merck & Co. (Rahway, NJ)
- …expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactor scale -up and scale -down, as well as recent advances, and ... challenges in the fieldExpertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack record of accomplishments in upstream bioprocessing with a history of… more
- Insmed Incorporated (San Diego, CA)
- …author development reports.Demonstrated experience with process validation and scale -down models for biopharmaceutical processes, including interpretation of results ... reporting that stands up to regulatory inspection.Demonstrated expert knowledge of scale -up principles with respect to viral vector purification.Work on complex… more
- Twist BioScience (South San Francisco, CA)
- …opportunity to help shape the team's systems and processes as we continue to scale with the growth of the company. This is a high-visibility, high-impact role within ... storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers. Twist Bioscience Corporation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …processes, instrumentation, and equipment start-ups from the laboratory through manufacturing scale . This role will be part of a Manufacturing Engineering team ... Experience A minimum of seven (7) years' experience in medium to large scale pharmaceutical or biotechnology process is required with a Bachelor's degree. At least… more
- Aequor (Bothell, WA)
- …degree in a scientific discipline. Laboratory practices such as use of analytical scale , pH meter and pipettors Aseptic technique involving the use of a biosafety ... cabinet. Algebra skills for volume and weight conversions. Data extrapolation and reporting. Good oral, written, and interpersonal communication skills Problem solving Working independently and multitasking. Preferred Qualifications: Bachelor's degree in a… more
- Merck & Co. (Rahway, NJ)
- …in designing appropriate DOE studies to inform on risks.Experience with process scale -up, definition of critical attributes, and technology transfer of early phase ... and/or late phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong understanding of integration and… more
- Merck & Co. (Rahway, NJ)
- …and building team self-sufficiency.3 years of experience leading multiple large- scale automation initiatives, including data management and data governance.Ability ... to work in a dynamic environment, handling and prioritizing many simultaneous assignments.Demonstrated skills in written, verbal, and interpersonal communication, technical problem-solving, and building partnerships.Strong leadership and team-building skills,… more
- Aequor (Pearl River, LA)
- …taps, etc. Activities will include executing techniques such as large- scale centrifugation, depth filtration, chromatography column purification and packing, ... tangential flow filtration, and clean-in-place and steam-in-place of process equipment. Other duties will include the cleaning and preparation of workspaces and biosafety cabinets. The incumbent should be proficient in aseptic technique, preventive… more
- Merck & Co. (Rahway, NJ)
- …needs related to new products undergoing process development, new products undergoing scale -up, launch and transfer to the supply network and existing commercial ... products undergoing process optimization. Support is inclusive of both start-up operations (FLEx Sterile1) and new capital build (FLEx Sterile2).Primary responsibility will be to maintain all equipment in accordance with GMP and Safety requirements, as well as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or PhD) preferred.Minimally 12+ years of combined experience 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… more
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