- Merck & Co. (Rahway, NJ)
- …leadership will be instrumental in supporting DS commercialization, process characterization , control strategy development, tech transfer to internal and external ... commercialization. Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and… more
- Merck & Co. (Rahway, NJ)
- …Product analytical problem-solving and optimization, trace impurity quantitation, characterization studies, and cross-functional initiatives. The individual will ... and regulatory compliance.Excel in impurity isolation, unknown peak identification, characterization of degradation pathways, and trace impurity quantitation (eg,… more
- Aequor (East Syracuse, NY)
- …a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product ... samples to support upstream and downstream manufacturing process development, characterization , and process improvements. Document and evaluate experimental results… more
- Merck & Co. (Rahway, NJ)
- …technical teams focused on late-stage clinical process development, characterization , and technology transfer of biopharmaceutical drug substance processes. ... and manufacturing-scale studies to support commercial process validation and characterization . You'll design experiments, analyze data, and mentor junior staff,… more
- Merck & Co. (Rahway, NJ)
- …packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, ... robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate… more
- Aequor (South San Francisco, CA)
- …BLI. This will include (but is not limited to) assay development, hit characterization and ranking. The successful candidate has knowledge and experience in kinetic ... and affinity characterization binding assays using SPR instruments such as those...Preferred Qualifications A focus on kinetics and binding affinity characterization with experience using Carterra Biacore SPR and/or Sartorius… more
- Tris Pharma (Monmouth Junction, NJ)
- …to remain current with developments in analytical chemistry, physical characterization and pharmaceutical testingPrepares non-conformance, Out of Trend (OOT), Out ... licenses or certificates requiredStrong knowledge and experience of physical characterization , thermal, spectroscopic and chromatographic techniques and conceptsStrong knowledge… more
- Tris Pharma (Monmouth Junction, NJ)
- …II Monmouth Junction, NJDepartment: Analytical Research and Development and Characterization / Analytical Development, R&D DescriptionTris Pharma, Inc. ( ... finished products (FP) and stability (ST) samples and executes physical characterization studies to facilitate product understanding. The incumbent also performs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for all methodological and statistical aspects for safety signal detection and characterization for ongoing studies and compound level pooled clinical trial data of ... handling, lead the statistical support in safety signal detection, validation, characterization and reporting in collaboration with safety programming team, CSPV,… more
- Insmed Incorporated (San Diego, CA)
- …performing experiments ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part of ... stages, including process development, optimization, technology transfer, and process characterization of cGMP processes for viral vectors.Take responsibility for… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …of exploring next generation cell therapies using in-vivo CAR virusPerform functional characterization of T cells transduced with in-vivo CAR virus using multiple ... methods (T cells, CAR-T or TCR-T preferred), quantitative PCR and functional characterization of T cells (Cytotoxicity assay using Incucyte or xCelligence, and MLR… more
- Merck & Co. (Rahway, NJ)
- …in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by ... Manufacturing Processes, Mentorship, Metabolomics, Molecular Biology, Omics Technologies, Process Characterization , Project Leadership, Project Management, Proteomics, Scientific Leadership {+… more
- Merck & Co. (San Francisco, CA)
- …or manufacturing, including process or analytical development, characterization , technology transfer, validation/PPQ, commercial manufacturing, and process ... and ideas. Preferred Experience and Skills Process development and/or process characterization experience/deep understanding in drug substance and drug product in… more
- Lundbeck (Bothell, WA)
- …and assisting in laboratory experiments for bioprocess development, optimization, and characterization Timely and error-free completion of data entry in electronic ... lab notebooks (Benchling) Flexible schedule for daily reactor and shake-flask sampling activities, including weekend, evening, and holiday work Coordinate within the Upstream Development team and cross-functionally with the Downstream Process Development,… more
- Aequor (Thousand Oaks, CA)
- …team with broad capabilities in protein engineering, expression, purification, and characterization . The ideal candidate will have a strong background in ... biochemistry and hands-on experience with protein purification, especially involving biologic molecules, using various chromatography techniques in a lab-based environment. Proficiency with lab software such as Unicorn, Chromeleon, or ChromeLab is preferred,… more
- Merck & Co. (Rahway, NJ)
- …to develop safe and robust manufacturing processes through process characterization , technology transfer, validation, filing and supply support of late-stage ... projects in the small molecule pipeline.- Given the significant role of biocatalysis and enzymes in the portfolio, the ideal candidate should have a specific expertise in microbial fermentation and downstream processing and is expected to draw on their… more
- Aequor (MA)
- …next generation sequencing and data analysis, nucleic acid purification and characterization , take lead in high throughput gene synthesis and plasmid production, ... process automation and protocol development, improvement of quality and throughput, problem solving etc. Key responsibilities for position About growing with us for winning with us In this role you will : Independently plan, design, and execute synthetic… more
- Merck & Co. (Rahway, NJ)
- …2D-SDS-PAGE, 2D-DIGE, or 2D-DIBE technologies for HCP antibody reagents characterization .Knowledge or experience with polyclonal antibody purification from animal ... antisera and antibody conjugation techniques.Familiar with different types of immunoassay such as ELISA, Western blot, and knowledge of different technology platforms for quantitative and semi-quantitative determination of protein analyte using immunoassay… more
- Merck & Co. (Rahway, NJ)
- …appropriate in-process controls to ensure robust and efficient throughput.Develop characterization plans and prototype small-scale equipment to prove out concepts ... prior to implementation.Conduct testing using tensile tester or other laboratory equipment and analyze data to inform process development activities.Assist clinical manufacturing team with authoring relevant SOPs and specifications to enable clinical batch… more
- Merck & Co. (Rahway, NJ)
- …biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes ... by improving efficiency and cost effectiveness through research and innovation, while assessing technologies and industry best practicesCollaborate with academia, industry, and vendors to drive development and early adoption of novel process… more
