- Merck & Co. (Lower Gwynedd, PA)
- …design, develop, and support bioanalytical vaccine immunogenicity assays to support regulated preclinical and clinical vaccine development. The individual ... responsible to contribute with limited supervision to all hands-on laboratory aspects of bioanalytical assay development, qualification/validation, technology transfer,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to support the manufacturing of autologous CAR-T products for clinical and commercial operation in a Controlled cGMP environment.Providing expertise in ... complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations, corrections and/or CAPAs.Represent and … more
- Merck & Co. (Lower Gwynedd, PA)
- …and/or assay format selection based on risk assessment and fit-for-purpose considerations. Support of pre- clinical / clinical sample analysis as needed. ... clinical applications. Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) is strongly desired. Demonstrated supervision and mentorship of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near ... cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, Central &… more
- Merck & Co. (Rahway, NJ)
- …position will be responsible for providing engineering leadership and cross-functional project support at the Rahway, NJ FLEx (Formulation, Laboratory & ... responsibilities include supporting the engineering and maintenance aspects of clinical operations, including support /initiation and gatekeeping of work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively ... or specialty medicines are being discussed. Develop a QA structure that could support GLP/non-GLP/ GCLP Research activities at the global level. Support through… more
- Merck & Co. (Rahway, NJ)
- …teams in both R&D and manufacturing to advance the biologics pipelineConduct laboratory -scale and/or pilot-scale studies to support scale-up and tech transfer ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
- Aequor (Bothell, WA)
- …in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for recombinant ... proteins and biological macromolecules for early- and late-phase clinical trials. The responsibilities of this position include but are not limited to designing and… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Formulation, Laboratory , and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product ... development and clinical manufacturing facility in Rahway, New Jersey.- This team...safety and quality representatives.Foster culture of collaboration, learning and innovation. Support in setting specific and measurable short- and long-term… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused ... understanding of all Quality Control functions and business areas. May need supervision/ support to resolve some sophisticated issues. He/ She will serve as technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... the Health Authority (eg, US FDA and EU EMA) for assigned projects with support , on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2,… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... passion for mentoring and working along others in a laboratory setting.- Applicants must have effective organizational and multi-tasking...and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... life-changing medicines.Design and conduct lab and/or pilot-scale studies to support mechanistic understanding, scale-up, and transfer of processes to manufacturing.… more
- Merck & Co. (South San Francisco, CA)
- …independent bench scientist to drive assay development and optimization to support drug development, target identification and validation activities in close ... (BS) or 5-7 (MS) years respectively of relevant professional laboratory research experience.Specific Responsibilities:Employ innovative molecular and cell biology… more
- Insmed Incorporated (San Diego, CA)
- …ranging from purification development and optimization, process characterization, and clinical manufacturing support . As part of this collaborative ... a non-supervisory position.ResponsibilitiesExecute technical strategies for purification process development to support pre- clinical and clinical programs at… more
- Insmed Incorporated (San Diego, CA)
- …the Technical Operations team as an Associate Director of MSAT where you will support pipeline programs that change lives. At Insmed Gene Therapy, you will be part ... Development and CMC teams you will be the bridge between the laboratory and GMP manufacturing.ResponsibilitiesWorks with management to plan and execute the MSAT… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …trainings to support the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. This position is ... in a manner consistent with safety policies, quality systems, and cGMP requirements. Support in daily completion of QC testing related to the manufacturing of… more
- University of Maryland Medical System (Easton, MD)
- …20 employers in the state of Maryland. No organization will give you the clinical variety, the support , or the opportunities for professional growth that you'll ... checking of requisitions for proper data entry. May operate simple medical laboratory equipment, such as a centrifuge and microscope. Effectively communicates with … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing routine Environmental Monitoring sampling of the LVV facility to support clinical trials and commercial operations in a controlled GMP ... to the manufacturing of LVV used for autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environmentResponsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom ... environment.Key Responsibilities Successfully support the implementation, execution, and improvement of the internal audit process. Support the planning and… more
